Home > Boards > US OTC > Medical - Healthcare > InVivo Therapeutics Holdings Corp (NVIV)

Clinical trial, last update 2/3/2020

Public Reply | Private Reply | Keep | Last ReadPost New MsgNext 10 | Previous | Next
XenaLives Member Profile
Member Level 
Followed By 332
Posts 44,662
Boards Moderated 26
Alias Born 09/20/01
160x600 placeholder
Statement of Ownership (sc 13g) Edgar (US Regulatory) - 10/23/2020 4:39:28 PM
InVivo Therapeutics Announces Pricing of $15.0 Million Public Offering Business Wire - 10/22/2020 9:15:00 AM
Securities Registration Statement (s-1) Edgar (US Regulatory) - 10/7/2020 6:01:32 AM
InVivo Therapeutics Announces Presentation at the Upcoming H.C Wainwright Virtual Global Investment Conference Business Wire - 9/11/2020 8:30:00 AM
Quarterly Report (10-q) Edgar (US Regulatory) - 8/11/2020 4:15:47 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 8/5/2020 4:34:29 PM
Statement of Changes in Beneficial Ownership (4) Edgar (US Regulatory) - 6/23/2020 6:37:34 PM
Proxy Statement (definitive) (def 14a) Edgar (US Regulatory) - 6/22/2020 6:04:21 AM
Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) Edgar (US Regulatory) - 6/9/2020 4:31:40 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 6/5/2020 4:06:18 PM
Notice of Effectiveness (effect) Edgar (US Regulatory) - 6/5/2020 6:01:40 AM
Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) Edgar (US Regulatory) - 6/4/2020 4:35:19 PM
Securities Registration Statement (s-1) Edgar (US Regulatory) - 5/22/2020 5:26:10 PM
Quarterly Report (10-q) Edgar (US Regulatory) - 5/13/2020 4:07:21 PM
Small Company Offering and Sale of Securities Without Registration (d) Edgar (US Regulatory) - 4/28/2020 4:15:49 PM
Statement of Ownership (sc 13g) Edgar (US Regulatory) - 4/24/2020 5:05:10 PM
Statement of Ownership (sc 13g) Edgar (US Regulatory) - 4/24/2020 4:15:10 PM
Statement of Ownership (sc 13g) Edgar (US Regulatory) - 4/24/2020 11:19:24 AM
InVivo Therapeutics Announces Closing of $3.0 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules Business Wire - 4/17/2020 12:19:00 PM
Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) Edgar (US Regulatory) - 4/17/2020 6:01:44 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 4/16/2020 5:20:33 PM
Statement of Ownership (sc 13g) Edgar (US Regulatory) - 4/16/2020 11:30:13 AM
InVivo Therapeutics Announces $3.0 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules Business Wire - 4/15/2020 7:30:00 PM
Statement of Ownership (sc 13g) Edgar (US Regulatory) - 3/16/2020 4:45:23 PM
Statement of Changes in Beneficial Ownership (4) Edgar (US Regulatory) - 3/12/2020 7:02:36 PM
XenaLives Member Level  Tuesday, 02/18/20 07:08:16 AM
Re: None
Post # of 6165 
Clinical trial, last update 2/3/2020

Quote:

Brief Summary:
This is a randomized, controlled, single-blind, multicenter, two Arm (Treatment or "Scaffold" Arm; Standard of Care or "Comparator" Arm) of a Neuro-Spinal Scaffold to evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12 spinal cord injury as compared to standard of care open spine surgery.

Condition or disease Intervention/treatment Phase
Injury, Spinal Cord
Device: Neuro-Spinal Scaffold
Not Applicable

Detailed Description:
This is a randomized, controlled, single blind, two-arm, multicenter Humanitarian Device Exemption (HDE) 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 as compared to standard of care open spine surgery. Subjects will be randomized in a blinded manner to one of two study arms, the Treatment or "Scaffold" Arm and the Standard of Care or "Comparator" Arm. Subjects in the Scaffold Arm will have the Scaffold implantation immediately following standard of care open spine surgery. Subjects in the Comparator Arm will have standard of care open spine surgery and will not receive the Scaffold. The subjects will be blinded to their study arm for the duration of the study.

Primary Objective: To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12 spinal cord injury as compared to standard of care open spine surgery.

Regulatory Objective: To enhance the clinical evidence for the Scaffold in the treatment of complete thoracic spinal cord injuries.

Intended Use: The Scaffold is intended for use in patients age 16-70 years diagnosed with a T2-T12 neurological level of injury functionally complete (AIS A) spinal cord injury for whom open spine surgery, (e.g., laminectomy, spine stabilization) which allows access to the dura of the injured spinal cord, is recommended as an option. The Scaffold is intended to be implanted in a cavity at the epicenter of the spinal cord contusion during open spine surgery. The Scaffold is intended for use in recent (=7 days) spinal cord injuries that do not involve penetrating injury to the cord or complete severing of the cord.



https://clinicaltrials.gov/ct2/show/NCT03762655?term=invivo+scaffold&draw=3&rank=3#contacts


Public Reply | Private Reply | Keep | Last ReadPost New MsgNext 10 | Previous | Next
Follow Board Follow Board Keyboard Shortcuts Report TOS Violation
X
Current Price
Change
Volume
Detailed Quote - Discussion Board
Intraday Chart
+/- to Watchlist
Consent Preferences