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Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI

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ClinicalTrials.gov Identifier: NCT03105882
Recruitment Status : Withdrawn (Study did not enroll any subjects.)
First Posted : April 10, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
InVivo Therapeutics

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 10, 2017
Last Update Posted Date March 19, 2018
Actual Study Start Date  ICMJE March 30, 2017
Actual Primary Completion Date March 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
Incidence of all Adverse Device Effects of any kind/seriousness. [ Time Frame: 6 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 3, 2017)
  • American Spinal Injury Association Impairment Scale (AIS) improvement of one or more grade [ Time Frame: 6 months ]
    International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exams
  • Improvements in motor and sensory scores [ Time Frame: 6 months ]
    ISNCSCI exams
  • Improvements in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) [ Time Frame: 6 months ]
    GRASSP Assessment
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI
Official Title  ICMJE Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal Scaffold for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5 - T1 Neurological Levels
Brief Summary Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels The purpose of this study is to support an expansion to support marketing applications as well as future studies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Traumatic Cervical Acute Spinal Cord Injury
Intervention  ICMJE Device: Neuro-Spinal Scaffold
Experimental: Neuro-Spinal Scaffold
Study Arms  ICMJE Experimental: Neuro-Spinal Scaffold
Intervention: Device: Neuro-Spinal Scaffold
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 15, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2017)
10
Actual Study Completion Date  ICMJE March 15, 2018
Actual Primary Completion Date March 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 16-70 years of age, inclusive
  • AIS A classification of traumatic spinal cord injury with a neurological level within C5-T1 inclusive
  • Recent injury
  • Non-penetrating SCI

Exclusion Criteria:

  • Terminally ill subjects not likely to be able to participate in follow-up
  • Incomplete spinal cord injury (AIS B, C, D, and E injuries)
  • No identifiable intra-spinal cavity following myelotomy/irrigation in the contused spinal cord in which a Scaffold can be placed
  • Spinal cord injury associated with significant traumatic brain injury or coma that
  • Radiographic or visual evidence of parenchymal dissociation or anatomic transection as determined by the Investigator where the contusion completely bridges a full cross-section of the spinal cord
  • Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03105882
Other Study ID Numbers  ICMJE InVivo-100-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InVivo Therapeutics
Study Sponsor  ICMJE InVivo Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard Toselli, MD InVivo Therapeutics
PRS Account InVivo Therapeutics
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP