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Conservative Treatment of Gastrointestinal Fistulas by Endoscopic Injection of tSVFem

NCT04670276 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-12-17

No results posted yet for this study

Summary

Gastrointestinal (GI) fistula is a complex condition with high mortality and requiring a multidisciplinary management.

The aim of this study is to exploit the regenerative-tissue capacities of autologous emulsified adipose tissue-derived stromal vascular fraction (tSVFem, widely used in other medical fields - like plastic surgery -for different purposes) harvested and delivered locally by endoscopy to close the GI fistula.

The proposed technique for the treatment of GI fistulas with tSVFem requires a minimal, inexpensive, easily reproducible mechanical manipulation of autologous adipose tissue without necessity of any enzymatic digestion or cell expansion.

Conditions

  • Gastrointestinal Fistula

Interventions

PROCEDURE

injection of emulsified adipose tissue stromal vascular fraction

Endoscopic injection of 10 cc of autologous microfat into the fistula (through a 6-French catheter), until it was completely filled, and a total of 1-2 cc of tSVFem (through a 22G endoscopic needle) into the submucosa of the 4 quadrants of the fistula borders, to obliterate it completely.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Venanzio Porziella, MD · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2022-03-02
Completion
2022-04-10

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 NCT04670276 on ClinicalTrials.gov