Comparison of the Therapeutic Effects of Balloon Assisted Enteroscopy Assisted Narrow Incision an… (NCT07409376) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of the Therapeutic Effects of Balloon Assisted Enteroscopy Assisted Narrow Incision and Balloon Dilation in the Treatment of Crohn's Disease Small Intestinal Stenosis
100 participantsStarted 2026-03-01
Plain-language summary
This study is designed as a controlled trial to evaluate the efficacy of balloon-assisted enteroscopy-guided radial incision therapy for the treatment of stricturing small bowel Crohn's disease. The study aims to compare therapeutic outcomes, procedure-related complications, and recurrence rates in patients with stricturing small bowel Crohn's disease undergoing balloon-assisted enteroscopy-guided radial incision therapy. The results are expected to provide a novel and reliable treatment option for patients with stricturing Crohn's disease and to lay a foundation for improving disease-related symptoms and quality of life.
Who can participate
Age range
16 Years – 75 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 between 16 and 75 years.
. Diagnosis of Crohn's disease with primary or secondary small bowel stricture confirmed by imaging studies, or small bowel stricture identified by enteroscopy.
. Inadequate response to conventional medical therapy and step-up treatment strategies.
. Stricture length less than 5 cm.
. Signed informed consent form.
Exclusion criteria
. Bowel wall thickening with Limberg grade IV blood flow on intestinal ultrasound, or presence of complications such as perforation, fistula, deep ulcer, inflammatory mass, or abscess.
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 not requiring additional therapeutic interventions at 1-year follow-up
Timeframe: 1 year
Trial details
NCT IDNCT07409376
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University