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NCT06616025 · ClinicalTrials.gov registry record · Phase 3
This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
A Phase 3 study of Peripheral Nerve Injury Upper Limb and Peripheral Nerve Injury (PNI), sponsored by Neuraptive Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
- 7
- Study locations
NCT06616025: Recruiting Phase 3 study of Peripheral Nerve Injury Upper Limb and Peripheral Nerve Injury (PNI), sponsored by Neuraptive Therapeutics.
NCT06616025 is a Phase 3 study of Peripheral Nerve Injury Upper Limb and Peripheral Nerve Injury (PNI) that is actively recruiting participants, run by Neuraptive Therapeutics. The registered enrollment target is 98 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06616025, a Phase 3 study of Peripheral Nerve Injury Upper Limb and Peripheral Nerve Injury (PNI), is actively recruiting participants, sponsored by Neuraptive Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
- 7
- Study locations
Study Summary
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.
Primary Outcome
The subject will complete the MHQ questionnaire at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48. A measure of the mean of MHQ in the Two Domains, Activities of Daily Living and Pain Scores, at Week 24 in the NTX-001 group as compared to Standard of Care (SoC). In the ADL subdomain, a higher component score indicates better function. In the Pain subdomain, a higher component score indicates greater pain. A total MHQ score of 100 is considered the best functional score.
Conditions Studied
Interventions
- COMBINATION_PRODUCT NTX-001 (PEG-Fusion)
Study Locations (7)
Missouri
- Missouri Orthopaedic Institute - Columbia
- Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St. - St Louis
Florida
- Orlando Health Orlando Regional Medical Center - Orlando
Illinois
- University of Chicago - Chicago
Maryland
- Curtis National Center at MedStar Union Memorial Hospital - Baltimore
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Washington
- Harborview Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2025-02-10 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 3 |
What NCT06616025 shows while recruiting
NCT06616025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Peripheral Nerve Injury Upper Limb appearing as the primary indexed condition, and to 1 intervention - of which NTX-001 (PEG-Fusion) is the first listed.
NCT06616025 lists 7 locations in 6 states (Missouri, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT06616025 about?
NCT06616025 is a clinical study titled "This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.". NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.
What is the current status of trial NCT06616025?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2025-02-10. Estimated completion is 2027-04-30.
What conditions does trial NCT06616025 study?
This clinical trial studies the following conditions: Peripheral Nerve Injury Upper Limb, Peripheral Nerve Injury (PNI).
What interventions are being tested in trial NCT06616025?
The interventions under investigation include: NTX-001 (PEG-Fusion) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06616025?
This trial is sponsored by Neuraptive Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06616025 being conducted?
This trial has 7 study locations across Florida, Illinois, Maryland, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06616025's enrollment target sits among peer trials
98 1715th of 2000 higher than 283 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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