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The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02138110
Recruitment Status : Active, not recruiting
First Posted : May 14, 2014
Results First Posted : December 28, 2018
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
InVivo Therapeutics

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Traumatic Thoracic Acute Spinal Cord Injury
Intervention Device: Neuro-Spinal Scaffold
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neuro-Spinal Scaffold
Hide Arm/Group Description Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Period Title: Enrolled in Study
Started 20
Completed 20
Not Completed 0
Period Title: Enrolled for Scaffold Implantation
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Physician Decision             1
Period Title: Overall Scaffold Implantation
Started 19
6-month Follow-Up 16
Completed 16
Not Completed 3
Reason Not Completed
Death             3
Arm/Group Title Neuro-Spinal Scaffold
Hide Arm/Group Description

Implantation of neuro-spinal scaffold in a cavity at the epicenter of the spinal cord contusion during open spine surgery.

Neuro-Spinal Scaffold

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
All enrolled subjects minus screen failures.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
36
(18 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
4
  20.0%
Male
16
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
4
  20.0%
Not Hispanic or Latino
16
  80.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 20 participants
American Indian or Alaskan Native
1
   5.0%
Black or African American
2
  10.0%
White
16
  80.0%
Other
1
   5.0%
Height  
Mean (Full Range)
Unit of measure:  Cm
Number Analyzed 20 participants
172
(147 to 185)
Weight  
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 20 participants
83
(58 to 127)
Body Mass Index  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 20 participants
28
(20 to 38)
Cause of Injury  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Fall
5
  25.0%
Other-All Terrain Vehicle
1
   5.0%
Vehicular
14
  70.0%
1.Primary Outcome
Title Percentage of Patients With Improvement in AIS Grade of One or More Levels
Hide Description

The ASIA (American Spinal Injury Association) Impairment Scale (AIS) classifies spinal cord injuries as follows:

A = Complete: no sensory or motor function is preserved in the sacral segments S4-S5

B = Sensory incomplete: sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5, AND no motor function is preserved more than three levels below the motor level on either side of the body

C = Motor incomplete: motor function is preserved below the neurological level, and more than half of key muscle functions below the single neurological level of injury have a muscle grade less than 3 (Grades 0-2)

D = Motor incomplete: at least half (half or more) of key muscle functions below the NLI have a muscle grade >3

E = Normal

The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.

Time Frame 6 months post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Endpoint Analysis Set includes all subjects who had a successful Neuro-Spinal Scaffold implant, no major data protocol deviations, and completed the 6-month Primary Endpoint Follow-up Visit.
Arm/Group Title Neuro-Spinal Scaffold
Hide Arm/Group Description:
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of patients
44
2.Secondary Outcome
Title Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months
Hide Description

The neurological level of injury (NLI) refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided that there is normal (intact) sensory and motor function rostrally.

A caudal change is an improvement in NLI whereas a rostral change is a deterioration in NLI.

The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.

Time Frame 6 months post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neuro-Spinal Scaffold
Hide Arm/Group Description:
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Caudal change in NLI from baseline
5
  31.3%
Rostral change in NLI from baseline
8
  50.0%
No change in NLI from baseline
3
  18.8%
3.Secondary Outcome
Title Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score
Hide Description

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Pin Prick Scores were assessed on a scale from 0 to 2 for each sensory point tested on each side of the body (maximum score = 112), with higher scores indicating better neurologic function.

The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.

An improvement in pin prick score indicates an increase in score from baseline at 6-months A deterioration in pin prick score indicates a decrease in score from baseline at 6-months No change in pin prick score indicates no change in score from baseline at 6-months

Time Frame 6 months post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neuro-Spinal Scaffold
Hide Arm/Group Description:
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement
10
  62.5%
Deterioration
6
  37.5%
No change
0
   0.0%
4.Secondary Outcome
Title Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score
Hide Description

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Light Touch Scores were assessed on a scale from 0 to 2 for each sensory point tested on each side of the body (maximum score = 112), with higher scores indicating better neurologic function.

The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.

An improvement in light touch score indicates an increase in light touch score from baseline at 6-months A deterioration in light touch score indicates a decrease in light touch score from baseline at 6-months No change in light touch score indicates no change in light touch score from baseline at 6-months

Time Frame 6 months post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neuro-Spinal Scaffold
Hide Arm/Group Description:
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement
10
  62.5%
Deterioration
4
  25.0%
No change
2
  12.5%
5.Secondary Outcome
Title Change From Baseline in ISNCSCI Total Motor Score
Hide Description

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Total Motor Scores were assessed on a scale from 0 to 5 for each myotome tested on each side of the body (upper limb maximum score = 50 and lower limb maximum score = 50), with higher scores indicating better neurologic function.

The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.

An improvement in motor score indicates an increase in motor score from baseline at 6-months A deterioration in motor score indicates an decrease in motor score from baseline at 6-months No change in motor score indicates no change in motor score from baseline at 6-months

Time Frame 6 months post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
Results from 15 of 16 patients are presented. This is because pre-implantation assessment was not testable for 1 of 16 patients.
Arm/Group Title Neuro-Spinal Scaffold
Hide Arm/Group Description:
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement
1
   6.7%
Deterioration
0
   0.0%
No Change
14
  93.3%
6.Secondary Outcome
Title Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence)
Hide Description

Characteristics of spinal cord anatomy were assessed by a Board-certified neuroradiologist central reader including presence or absence of intraparenchymal cysts.

Screening MRI was used as the baseline value.

Time Frame 6 months post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neuro-Spinal Scaffold
Hide Arm/Group Description:
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Cyst Detected
9
  56.3%
No Cyst Detected
5
  31.3%
Indeterminate
2
  12.5%
7.Secondary Outcome
Title Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence)
Hide Description

Characteristics of spinal cord anatomy were assessed by a Board-certified neuroradiologist central reader including the presence or absence of spinal cord adhesion.

Screening MRI was used as the baseline value.

Time Frame 6 months post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neuro-Spinal Scaffold
Hide Arm/Group Description:
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Spinal Cord Adhesion Detected
1
   6.3%
No Spinal Cord Adhesion Detected
13
  81.3%
Indeterminate
2
  12.5%
Time Frame Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neuro-Spinal Scaffold
Hide Arm/Group Description Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
All-Cause Mortality
Neuro-Spinal Scaffold
Affected / at Risk (%)
Total   3/19 (15.79%)    
Hide Serious Adverse Events
Neuro-Spinal Scaffold
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Gastrointestinal disorders   
Colitis  1  1/19 (5.26%)  1
Diarrhoea  1  1/19 (5.26%)  1
Infections and infestations   
Cellulitis  1  1/19 (5.26%)  1
Clostridium difficile colitis  1  1/19 (5.26%)  1
Epididymitis  1  1/19 (5.26%)  1
Postoperative wound infection  1  1/19 (5.26%)  1
Sepsis  1  1/19 (5.26%)  1
Urinary tract infection  1  2/19 (10.53%)  4
Injury, poisoning and procedural complications   
Pneumothorax traumatic  1  1/19 (5.26%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Necrotising myositis  1  1/19 (5.26%)  1
Nervous system disorders   
Cerebrospinal fluid leakage  1  1/19 (5.26%)  1
Cerebrovascular accident  1  1/19 (5.26%)  1
Spinal cord disorder  1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  2/19 (10.53%)  2
Pulmonary embolism  1  2/19 (10.53%)  2
Respiratory distress  1  1/19 (5.26%)  2
Respiratory failure  1  1/19 (5.26%)  2
Vascular disorders   
Deep vein thrombosis  1  1/19 (5.26%)  1
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neuro-Spinal Scaffold
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  3/19 (15.79%)  4
Leukocytosis  1  6/19 (31.58%)  7
Neutropenia  1  1/19 (5.26%)  1
Thrombocytopenia  1  2/19 (10.53%)  2
Thrombocytosis  1  1/19 (5.26%)  1
Cardiac disorders   
Cardiac arrest  1  1/19 (5.26%)  1
Tachycardia  1  2/19 (10.53%)  2
Ear and labyrinth disorders   
Vertigo  1  1/19 (5.26%)  1
Gastrointestinal disorders   
Abdominal distension  1  6/19 (31.58%)  6
Abdominal pain  1  2/19 (10.53%)  2
Anal fissure  1  1/19 (5.26%)  1
Anal ulcer  1  1/19 (5.26%)  1
Colitis  1  1/19 (5.26%)  1
Colitis ischaemic  1  1/19 (5.26%)  1
Constipation  1  4/19 (21.05%)  4
Diarrhoea  1  3/19 (15.79%)  4
Dry mouth  1  2/19 (10.53%)  3
Dyspepsia  1  1/19 (5.26%)  2
Dysphagia  1  1/19 (5.26%)  1
Gastrooesophageal reflux disease  1  1/19 (5.26%)  1
Haemorrhoids  1  3/19 (15.79%)  3
Ileus  1  1/19 (5.26%)  1
Inguinal hernia  1  1/19 (5.26%)  1
Intestinal ischaemia  1  1/19 (5.26%)  1
Nausea  1  4/19 (21.05%)  5
Proctitis  1  1/19 (5.26%)  1
Rectal haemorrhage  1  1/19 (5.26%)  1
Tooth impacted  1  1/19 (5.26%)  1
Vomiting  1  2/19 (10.53%)  2
Abdominal pain upper  1  1/19 (5.26%)  1
General disorders   
Adverse drug reaction  1  1/19 (5.26%)  1
Chest pain  1  1/19 (5.26%)  1
Fatigue  1  1/19 (5.26%)  1
Generalised oedema  1  1/19 (5.26%)  1
Medical device complication  1  1/19 (5.26%)  2
Non-cardiac chest pain  1  1/19 (5.26%)  1
Oedema peripheral  1  2/19 (10.53%)  2
Pain  1  2/19 (10.53%)  2
Pyrexia  1  8/19 (42.11%)  8
Systemic inflammatory response syndrome  1  1/19 (5.26%)  1
Injection site pain  1  1/19 (5.26%)  1
Hepatobiliary disorders   
Hyperbilirubinaemia  1  1/19 (5.26%)  1
Immune system disorders   
Drug hypersensitivity  1  1/19 (5.26%)  1
Infections and infestations   
Bacterial infection  1  1/19 (5.26%)  1
Bronchitis  1  1/19 (5.26%)  1
Candiduria  1  1/19 (5.26%)  1
Cellulitis  1  2/19 (10.53%)  2
Cellulitis of male external genital organ  1  1/19 (5.26%)  1
Clostridium difficile colitis  1  1/19 (5.26%)  1
Clostridium difficile infection  1  1/19 (5.26%)  1
Enterococcal infection  1  1/19 (5.26%)  1
Fungal skin infection  1  1/19 (5.26%)  1
Impetigo  1  1/19 (5.26%)  1
Localised infection  1  1/19 (5.26%)  1
Meningitis  1  1/19 (5.26%)  1
Nasopharyngitis  1  1/19 (5.26%)  1
Pneumonia  1  1/19 (5.26%)  1
Septic shock  1  1/19 (5.26%)  1
Serratia infection  1  1/19 (5.26%)  1
Streptococcal urinary tract infection  1  1/19 (5.26%)  1
Tinea pedis  1  1/19 (5.26%)  1
Urinary tract infection  1  12/19 (63.16%)  38
Injury, poisoning and procedural complications   
Anaemia postoperative  1  1/19 (5.26%)  1
Cartilage injury  1  1/19 (5.26%)  1
Chemical peritonitis  1  1/19 (5.26%)  1
Contusion  1  1/19 (5.26%)  1
Fall  1  1/19 (5.26%)  1
Foot fracture  1  1/19 (5.26%)  2
Incision site pain  1  4/19 (21.05%)  4
Laceration  1  1/19 (5.26%)  1
Nail avulsion  1  1/19 (5.26%)  1
Postoperative respiratory failure  1  1/19 (5.26%)  1
Procedural nausea  1  1/19 (5.26%)  1
Procedural pain  1  2/19 (10.53%)  2
Thermal burn  1  2/19 (10.53%)  3
Wound  1  1/19 (5.26%)  1
Investigations   
Alanine aminotransferase increased  1  1/19 (5.26%)  1
Ammonia increased  1  1/19 (5.26%)  1
Aspartate aminotransferase increased  1  1/19 (5.26%)  1
Blood alkaline phosphatase increased  1  1/19 (5.26%)  1
Blood creatine phosphokinase increased  1  1/19 (5.26%)  2
Blood creatinine increased  1  1/19 (5.26%)  1
Blood lactate dehydrogenase increased  1  1/19 (5.26%)  1
Blood prolactin increased  1  1/19 (5.26%)  1
Blood urea increased  1  1/19 (5.26%)  1
Body temperature fluctuation  1  1/19 (5.26%)  1
Body temperature increased  1  1/19 (5.26%)  1
C-reactive protein increased  1  1/19 (5.26%)  1
Hepatic enzyme increased  1  1/19 (5.26%)  1
Red blood cell sedimentation rate increased  1  1/19 (5.26%)  1
White blood cell count increased  1  1/19 (5.26%)  1
Blood glucose increased  1  1/19 (5.26%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/19 (5.26%)  1
Hypocalcaemia  1  2/19 (10.53%)  2
Hypokalaemia  1  1/19 (5.26%)  1
Hypophosphataemia  1  4/19 (21.05%)  4
Malnutrition  1  1/19 (5.26%)  1
Metabolic acidosis  1  1/19 (5.26%)  1
Vitamin D Deficiency  1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  5/19 (26.32%)  5
Back pain  1  5/19 (26.32%)  7
Groin pain  1  2/19 (10.53%)  2
Muscle spasms  1  11/19 (57.89%)  15
Musculoskeletal chest pain  1  1/19 (5.26%)  1
Musculoskeletal discomfort  1  1/19 (5.26%)  1
Musculoskeletal pain  1  3/19 (15.79%)  6
Myalgia  1  2/19 (10.53%)  2
Neck pain  1  3/19 (15.79%)  3
Necrotising myositis  1  1/19 (5.26%)  1
Pain in extremity  1  5/19 (26.32%)  9
Rhabdomyolysis  1  1/19 (5.26%)  1
Nervous system disorders   
Cerebral haemorrhage  1  1/19 (5.26%)  1
Syringomyelia  1  1/19 (5.26%)  1
Aphasia  1  1/19 (5.26%)  1
Dizziness  1  2/19 (10.53%)  2
Dysaesthesia  1  1/19 (5.26%)  1
Headache  1  5/19 (26.32%)  5
Lethargy  1  1/19 (5.26%)  1
Migraine  1  2/19 (10.53%)  2
Muscle spasticity  1  4/19 (21.05%)  6
Myelomalacia  1  2/19 (10.53%)  3
Neuralgia  1  10/19 (52.63%)  12
Neurological decompensation  1  1/19 (5.26%)  1
Paraesthesia  1  2/19 (10.53%)  2
Peripheral sensory neuropathy  1  1/19 (5.26%)  1
Poor quality sleep  1  1/19 (5.26%)  1
Spinal meningeal cyst  1  1/19 (5.26%)  1
Syncope  1  1/19 (5.26%)  1
Autonomic dysreflexia  1  1/19 (5.26%)  1
Psychiatric disorders   
Acute stress disorder  1  1/19 (5.26%)  1
Agitation  1  1/19 (5.26%)  1
Anxiety  1  4/19 (21.05%)  4
Depression  1  5/19 (26.32%)  8
Insomnia  1  3/19 (15.79%)  3
Mood swings  1  1/19 (5.26%)  1
Renal and urinary disorders   
Bladder pain  1  2/19 (10.53%)  2
Haematuria  1  1/19 (5.26%)  1
Incontinence  1  1/19 (5.26%)  1
Renal failure acute  1  1/19 (5.26%)  1
Urinary incontinence  1  4/19 (21.05%)  4
Reproductive system and breast disorders   
Acquired hydrocele  1  2/19 (10.53%)  2
Galactorrhoea  1  1/19 (5.26%)  1
Genital rash  1  1/19 (5.26%)  1
Scrotal oedema  1  1/19 (5.26%)  1
Scrotal pain  1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/19 (5.26%)  2
Atelectasis  1  4/19 (21.05%)  5
Dysphonia  1  1/19 (5.26%)  1
Hypoxia  1  1/19 (5.26%)  1
Increased bronchial secretion  1  1/19 (5.26%)  1
Lung consolidation  1  2/19 (10.53%)  2
Nasal congestion  1  1/19 (5.26%)  1
Oropharyngeal pain  1  2/19 (10.53%)  2
Pleural effusion  1  4/19 (21.05%)  6
Pneumonitis  1  1/19 (5.26%)  1
Pneumothorax  1  1/19 (5.26%)  2
Respiratory failure  1  3/19 (15.79%)  3
Tachypnoea  1  1/19 (5.26%)  1
Throat irritation  1  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders   
Blister  1  2/19 (10.53%)  4
Decubitus ulcer  1  5/19 (26.32%)  7
Night sweats  1  1/19 (5.26%)  1
Pruritus  1  1/19 (5.26%)  1
Rash  1  3/19 (15.79%)  4
Rash pruritic  1  1/19 (5.26%)  1
Skin fissures  1  1/19 (5.26%)  1
Skin ulcer  1  1/19 (5.26%)  1
Vascular disorders   
Deep vein thrombosis  1  1/19 (5.26%)  1
Haemorrhage  1  1/19 (5.26%)  1
Hypertension  1  2/19 (10.53%)  2
Hypotension  1  4/19 (21.05%)  4
Orthostatic hypotension  1  1/19 (5.26%)  1
Thrombophlebitis  1  1/19 (5.26%)  1
Venous occlusion  1  1/19 (5.26%)  1
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rich Toselli
Organization: InVivo Therapeutics Corporation
Phone: (617) 863-5540
EMail: rtoselli@invivotherapeutics.com
Layout table for additonal information
Responsible Party: InVivo Therapeutics
ClinicalTrials.gov Identifier: NCT02138110    
Other Study ID Numbers: InVivo-100-101
First Submitted: May 1, 2014
First Posted: May 14, 2014
Results First Submitted: December 6, 2018
Results First Posted: December 28, 2018
Last Update Posted: December 18, 2019