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Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas

NCT06798935 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-01-29

No results posted yet for this study

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.

Conditions

  • Rectovaginal Fistula
  • Anovaginal Fistula

Interventions

PROCEDURE

autologous platelet-rich stroma

Autologous platelet-rich stroma, which is the combined product of stromal vascular fraction and platelet-rich plasma

Sponsors & Collaborators

Principal Investigators

  • Oddeke van Ruler, GI- surgeon, MD, PhD · IJsselland Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-11
Primary Completion
2024-09-04
Completion
2024-09-04

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798935 on ClinicalTrials.gov