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Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT06798935•Erasmus Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•patients presenting with significant symptoms of a rectovaginal fistula (RVF)
•RVF confirmed on imaging or with a high suspicion based on imaging findings (magnetic resonance imaging \[MRI\] and/or endoanal ultrasound \[EUS\])

Exclusion Criteria

•Patients with active proctitis
•Patients with the presence of associated (not properly drained)) pelvic abscess
•Patients with immune suppressed status
•Patients with hematological disorders
•Patients with any oncological event in the five years prior to study

Locations (1)

Ijsselland Hospital

Capelle aan den IJssel, South Holland, Netherlands

Key Dates

Start Date

January 11, 2019

Primary Completion Date

September 4, 2024

Completion Date

September 4, 2024

Last Updated

January 29, 2025

Enrollment

ACTUAL participants

Conditions

Rectovaginal FistulaAnovaginal Fistula

Interventions

autologous platelet-rich stroma

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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