Evaluation of the Efficacy and Safety of Endoscopic Dilatation and Biological Therapy in Intestin… (NCT06603298) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of the Efficacy and Safety of Endoscopic Dilatation and Biological Therapy in Intestinal Stenosis Due to CD
Italy182 participantsStarted 2024-10-17
Plain-language 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 during the period January 2016 - June 2024 will be enrolled.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with transitable colonoscopy at 12 months assessed by endoscopic and radiological documentation