Traumatic Cervical Acute Spinal Cord InjuryNCT03105882
Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI
A study testing Neuro-Spinal Scaffold in people with Traumatic Cervical Acute Spinal Cord Injury, run by InVivo Therapeutics at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Traumatic Cervical Acute Spinal Cord Injury
- What is being tested?
- Neuro-Spinal Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2017to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Being tested
- Neuro-Spinal Scaffold
- Keywords
- Spinal Cord Injury, SCI, Complete (AIS A) Traumatic Acute Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-Spinal ScaffoldDevice
Experimental: Neuro-Spinal Scaffold
| Study group | Role | What they receive |
|---|---|---|
| Neuro-Spinal Scaffold | Experimental | Not described Receives: Device: Neuro-Spinal Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all Adverse Device Effects of any kind/seriousness.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start30 Mar 2017
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Why it stopped: Study did not enroll any subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Cervical Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- InVivo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Toselli, MD, Study director, InVivo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105882
- Sponsor's protocol ID
- InVivo-100-102
- Status last verified
- Mar 2018
- First submitted
- 29 Mar 2017
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03105882
- Acronym / sponsor ID
- InVivo-100-102
- Keywords
- Spinal Cord Injury, SCI, Complete (AIS A) Traumatic Acute Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not enroll any subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- InVivo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuro-Spinal Scaffold | Experimental | Device: Neuro-Spinal Scaffold |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro-Spinal ScaffoldExperimental: Neuro-Spinal Scaffold | Device | Neuro-Spinal Scaffold |
Primary outcome
Incidence of all Adverse Device Effects of any kind/seriousness.
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
Related trials for Traumatic Cervical Acute Spinal Cord Injury
Recruiting
Functional Electrical Stimulation vs Transcutaneous Stimulation in Patients With Subacute Spinal Cord Injury
Non Traumatic Spinal Cord Injury, Sub-Acute Rehabilitation
Enrolling by invitation
Duraplasty for Acute Traumatic Spinal Cord Injury
Spinal Cord Injury, Acute, Spinal Cord Injury (SCI), Initial Encounter
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Toselli, MD study director
InVivo Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-Spinal Scaffold in people with Traumatic Cervical Acute Spinal Cord Injury, run by InVivo Therapeutics at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all Adverse Device Effects of any kind/seriousness. (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.