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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
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
InVivo Therapeutics

May 1, 2014
May 14, 2014
March 16, 2018
April 2014
December 2017   (Final data collection date for primary outcome measure)
Proportion of subjects with improvement in AIS grade of one or more levels [ Time Frame: 6 months ]
A preset objective performance criterion (OPC) based upon this proportion will be used as the primary measure of success for this study.
Incidence of all Adverse Device Effects of any kind/seriousness. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT02138110 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with improvement in motor scores [ Time Frame: 6 months ]
  • Proportion of subjects with improvement in sensory scores [ Time Frame: 6 months ]
  • Proportion of subjects with improvement in hip abduction/adduction or great toe flexion/extension [ Time Frame: 6 months ]
  • Proportion of subjects with improvement in bowel function [ Time Frame: 6 months ]
  • Proportion of subjects with improvement in bladder function [ Time Frame: 6 months ]
  • Proportion of subjects with improvement in SCIM III [ Time Frame: 6 months ]
  • Proportion of subjects with improvement in QLI-SCI III [ Time Frame: 6 months ]
  • Proportion of subjects with decreased pain [ Time Frame: 6 months ]
  • Incidence of all Adverse Device Effects of any kind/seriousness. [ Time Frame: 6 months ]
ASIA score changes from baseline at 3 months, 6 months, and 12 months post implantation. [ Time Frame: 6 months ]
Not Provided
Not Provided
 
The INSPIRE Study: Probable Benefit of the Neuro- Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury
The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold(TM) for Safety and Neurologic Recovery in Subjects With Complete Thoracic AIS A Spinal Cord Injury
  • To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12/L1 spinal cord injury .
  • This is a Humanitarian Device Exemption (HDE) Probable Benefit Study to demonstrate safety and probable benefit in support of future studies and an HDE application with subsequent approval.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Traumatic Thoracic Acute Spinal Cord Injury
Device: Neuro-Spinal Scaffold
Experimental: Neuro-Spinal Scaffold
Intervention: Device: Neuro-Spinal Scaffold
Theodore N, Hlubek R, Danielson J, Neff K, Vaickus L, Ulich TR, Ropper AE. First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility. Neurosurgery. 2016 Aug;79(2):E305-12. doi: 10.1227/NEU.0000000000001283.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
5
Not Provided
December 2017   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Aged 16 - 70 years
  • AIS A traumatic spinal cord injury at neurological spinal cord level T2-T12/L1
  • Recent injury (must receive Scaffold within 96 hours from injury)
  • Non-penetrating contusion injury no less than approximately 4 mm diameter by MRI

Key Exclusion Criteria:

  • Incomplete spinal cord injury (AIS B, C, D, E)
  • Terminally ill
  • Spinal cord injury associated with traumatic brain injury
  • Subject on long term mechanical ventilation
  • Penetrating injuries
  • Radiographic or visual evidence of parenchymal dissociation or anatomic transection where the contusion completely bridges a full cross-section of the spinal cord
Sexes Eligible for Study: All
16 Years to 70 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada,   United Kingdom
 
NCT02138110
InVivo-100-101
Yes
Not Provided
Not Provided
InVivo Therapeutics
InVivo Therapeutics
Not Provided
Study Director: Richard Toselli, MD InVivo Therapeutics
InVivo Therapeutics
March 2018

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