Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement

NCT06813768 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-02-07

No results posted yet for this study

Summary

Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial

Conditions

  • Rectovaginal Fistula
  • Crohn Disease

Interventions

DEVICE

Microfractured adipose tissue injection and plug placement

surgery + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice and placement of a biological prosthesis

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Silvio Laureti, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-07
Primary Completion
2024-03-30
Completion
2025-03-30

Countries

  • Italy

Study Locations

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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 NCT06813768 on ClinicalTrials.gov