Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06798935
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2025-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas
Sponsor:
Erasmus Medical Center
Organization:
Study Overview
Official Title:
Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRS-RVF
Brief Summary:
Is the addition of platelet-rich stroma (PRS) injection, a form of autologous call therapy, to surgical treatment for rectovaginal fistula feasible and safe? The primary endpoints of this study are feasibility and safety until 12 months after surgery. Secondary endpoints include rates of clinical and radiological closure, recurrence rates after clinical or radiological closure and unplanned re-interventions within 12-month post-surgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: