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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2018-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Traumatic Cervical Acute Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Neuro-Spinal Scaffold

Group Type EXPERIMENTAL

Neuro-Spinal Scaffold

Intervention Type DEVICE

Experimental: Neuro-Spinal Scaffold

Interventions

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Neuro-Spinal Scaffold

Experimental: Neuro-Spinal Scaffold

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No