3D BIO-STRUCTURES FOR G.I. POST-SURGICAL DEFECTS

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to treat chronic gastrointestinal fistulae (CGF), which are abnormal connections that can form in the digestive system after surgery. The study aims to evaluate the safety and effectiveness of a special treatment using a patient's own fat tissue. This fat is processed into a liquid form and used to help create a 3D-printed scaffold, which acts like a framework to encourage the growth of the patient’s own cells and help repair the damaged area. The treatment will be delivered endoscopically, meaning it will be done through a small camera inserted into the body.

To be eligible for this trial, patients must be between the ages of 65 and 74, or 36 and 52, and have CGF that cannot be treated with traditional methods. This may include patients who have already tried other treatments without success or those for whom further surgery could be dangerous. Participants in the trial can expect to receive personalized treatment designed to enhance tissue healing and restore healthy bacteria in the gut. It’s important to note that patients must provide informed consent to participate, and certain conditions may disqualify them from joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • patients with CGF at any level that can be approached endoscopically and for whom the possibility of conventional conservative treatment is ruled out, or all possible conservative or surgical treatments have already been performed without benefit, or in whom the reiteration of such treatments is contraindicated, because of life-threatening, and/or possible complications, and/or disabling outcomes.
• Exclusion Criteria:
• • patients who have not given informed consent to the procedure;
• • patients with entero-enteral CGF,
• • patients who have therapeutic options of other type.