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Micro-fragmented Adipose Tissue and Complex Crohns' Anal Fistulas

NCT03555773 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-06-14

No results posted yet for this study

Summary

The study aims to evaluate safety, feasibility and effectiveness of local injections of autologous and micro-fragmented adipose tissue obtained with the Lipogems® system in patients with refractory complex fistulizing perianal Crohn's disease.

Conditions

  • Crohn Disease
  • Perianal Fistula

Interventions

PROCEDURE

Lipogems

After local surgical drainage of the perianal disease, micro-fragmented adipose tissue is injected circumferentially into the submucosa surrounding the internal fistula orifice and in the perianal tissue along the residual fistula tract.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Gilberto Poggioli, Prof · S. Orsola-Malpighi Hospital, Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-11
Primary Completion
2017-06-28
Completion
2017-06-28

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 NCT03555773 on ClinicalTrials.gov