Pilot Study of the Neuro-Spinal Scaffold for the Treatmen... | NCT03105882

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

NCT03105882

Sponsor

InVivo Therapeutics

Status

Withdrawn

Last Update Posted

Mar 19, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Traumatic Cervical Acute Spinal Cord Injury

Interventions

Neuro-Spinal Scaffold

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study did not enroll any subjects.

Expanded Access Info

Start Date

Mar 30, 2017Actual

Primary Completion Date

Mar 15, 2018Actual

Completion Date

Mar 15, 2018Actual

First Submitted Date

Mar 29, 2017

First Submission Date that Met QC Criteria

Apr 3, 2017

First Posted Date

Apr 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2018

Last Update Posted Date

Mar 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neuro-Spinal Scaffold	Experimental		Device: Neuro-Spinal Scaffold

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuro-Spinal Scaffold	Device	Experimental: Neuro-Spinal Scaffold	Neuro-Spinal Scaffold

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of all Adverse Device Effects of any kind/seriousness.		6 Months

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
American Spinal Injury Association Impairment Scale (AIS) improvement of one or more grade	International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exams	6 months
Improvements in motor and sensory scores

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Toselli, MD	InVivo Therapeutics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto Western Hospital		Toronto	Ontario	M5T 2S8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided