Status:
NOT_YET_RECRUITING
3D BIO-STRUCTURES FOR G.I. POST-SURGICAL DEFECTS
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
IRCCS Ospedale Casa Sollievo della Sofferenza
Conditions:
Fistula
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The study is focused on evaluating the safety and efficacy of using vascular stromal tissue, derived from autologous adipose tissue, and subjected to microfragmentation and emulsification (Stromal Vas...
Eligibility Criteria
Inclusion
- 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
- patients who have not given informed consent to the procedure;
- patients with entero-enteral CGF,
- patients who have therapeutic options of other type.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06587633
Start Date
October 1 2024
End Date
September 10 2026
Last Update
September 25 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino gemelli IRCCS
Roma, Italy