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NCT06632418 · ClinicalTrials.gov registry record · Phase 2
Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing
A Phase 2 study of Anal Fistula and Complex Perianal Fistula, sponsored by Alexander Hawkins.
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06632418: Active Phase 2 study of Anal Fistula and Complex Perianal Fistula, sponsored by Alexander Hawkins.
NCT06632418 is a Phase 2 study of Anal Fistula and Complex Perianal Fistula that is active but no longer recruiting, run by Alexander Hawkins. The registered enrollment target is 12 participants, below the 300-participant average among 5 other Anal Fistula trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06632418, a Phase 2 study of Anal Fistula and Complex Perianal Fistula, is active but no longer recruiting, sponsored by Alexander Hawkins.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The average success rate for healing and remission of complex perianal fistulas, idiopathic or Crohn's-related, is approximately 50%. These abnormal connections between the rectum and the outside skin remain a major clinical challenge in need of new treatments aimed at tissue repair. Platelet-derived growth factor drives wound healing and tissue regeneration, and manufactured PDGF is currently used to heal diabetic foot ulcers and regenerate bone in periodontal and orthopedic patients. Manufactured recombinant human PDGF has the potential to improve the success rate for complete healing of complex perianal fistulas, reduce the recurrence rate due to reopening of the fistula tract, and avoid complications associated with routine surgical interventions.
Primary Outcome
Proportion of participants with procedural success as defined by implantation of the device without device-related SAEs.
Conditions Studied
Interventions
- DRUG RhPDGF-BB
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-11-25 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What the registry record for NCT06632418 still lists
NCT06632418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 300-participant average among 5 other Anal Fistula trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Anal Fistula appearing as the primary indexed condition, and to 1 intervention - of which RhPDGF-BB is the first listed.
NCT06632418 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06632418 about?
NCT06632418 is a clinical study titled "Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing". The average success rate for healing and remission of complex perianal fistulas, idiopathic or Crohn's-related, is approximately 50%. These abnormal connections between the rectum and the outside skin remain a major clinical challenge in need of new treatments aimed at tissue repair. Platelet-derive...
What is the current status of trial NCT06632418?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2024-11-25. Estimated completion is 2026-10.
What conditions does trial NCT06632418 study?
This clinical trial studies the following conditions: Anal Fistula, Complex Perianal Fistula.
What interventions are being tested in trial NCT06632418?
The interventions under investigation include: RhPDGF-BB (DRUG).
Who is sponsoring clinical trial NCT06632418?
This trial is sponsored by Alexander Hawkins, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06632418 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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