3D BIO-STRUCTURES FOR G.I. POST-SURGICAL DEFECTS
Not Applicable
Not yet recruiting
- Conditions
- Fistula
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Inclusion Criteria:<br><br> - patients with CGF at any level that can be approached endoscopically and for whom<br> the possibility of conventional conservative treatment is ruled out, or all possible<br> conservative or surgical treatments have already been performed without benefit, or<br> in whom the reiteration of such treatments is contraindicated, because of<br> life-threatening, and/or possible complications, and/or disabling outcomes.<br><br>Exclusion Criteria:<br><br> - patients who have not given informed consent to the procedure;<br><br> - patients with entero-enteral CGF,<br><br> - patients who have therapeutic options of other type.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of the custom-made 3D printed vascular stromal tissue and scaffolds to treat CGFs.
- Secondary Outcome Measures
Name Time Method Evaluation of immunological response;Incidence of Treatment-Emergent Adverse Events