Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Efficacy and Safety of Endoscopic Dilatation and Biological Therapy in Intestinal Stenosis Due to CD
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Brief Summary
All patients with Crohn\'s disease, already undergoing biological therapy for the treatment of clinically significant intestinal stenosis and/or already undergoing endoscopic balloon dilatation du...
Detailed Description
All patients meeting all inclusion criteria and no exclusion criteria will be offered participation in the study upon presentation of the information form and signing of the informed consent for parti...
Eligibility Criteria
Inclusion
- Age ≥ 18 years,
- Confirmed diagnosis of Crohn\'s disease;
- Radiological or endoscopic evidence of Crohn\'s disease complicated by clinically significant intestinal stenosis treated by endoscopic balloon dilatation.
- Minimum 12-month clinical follow-up at this hospital;
- Ability to express and give informed consent for participation in the study and to adhere to the timetable of scheduled visits.
Exclusion
- Age \<18 years;
- Patients with pouch or terminal ileostomy;
- Any clinical condition that, in the opinion of the investigators, may contraindicate enrolment in the study;
- Unstable personality or inability to adhere to protocol procedures;
- Inability to express and give informed consent for study participation and to adhere to the participation in the study and to adhere to the timing of the planned visits.
Key Trial Info
Start Date :
October 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 17 2025
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT06603298
Start Date
October 17 2024
End Date
October 17 2025
Last Update
December 24 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
Roma, Italy, 00168