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

NCT02138110 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-17

Study results available
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Summary

This is an HDE probable benefit, open-label, non- randomized, single-arm, multicenter study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12.

Conditions

  • Traumatic Thoracic Acute Spinal Cord Injury

Interventions

DEVICE

Neuro-Spinal Scaffold

Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery

Sponsors & Collaborators

  • InVivo Therapeutics

    lead INDUSTRY

Principal Investigators

  • Richard Toselli, MD · InVivo Therapeutics Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-13
Primary Completion
2017-11-29
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02138110 on ClinicalTrials.gov