New incision technique may ease Crohn's bowel blockages
NCT ID NCT07409376
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two minimally invasive procedures for treating narrowed sections of the small intestine caused by Crohn's disease. About 100 participants will receive either a balloon dilation or a precise incision made during a special endoscopy. The goal is to see which approach better relieves symptoms and reduces the need for repeat treatments or surgery over one to three years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 16 and 75 years. 2. Diagnosis of Crohn's disease with primary or secondary small bowel stricture confirmed by imaging studies, or small bowel stricture identified by enteroscopy. 3. Inadequate response to conventional medical therapy and step-up treatment strategies. 4. Stricture length less than 5 cm. 5. Signed informed consent form. Exclusion Criteria: 1. 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. 2. Deep ulcer in the stricture segment observed by enteroscopy, potentially involving the muscular layer. 3. Presence of strictures in the esophagus, stomach, or duodenum. 4. Presence of colorectal stricture or ileocecal valve stricture. 5. Small bowel stricture complicated by abscess, fistula, or severe angulation. 6. Patients with ≥3 small bowel strictures or stricture length ≥5 cm. 7. Strictures previously treated with stent placement, dilation, or incision but without sustained symptom-free remission for at least 1 year. 8. Pregnancy or breastfeeding. 9. Inability to undergo endoscopic treatment. 10. Severe coagulation disorders (platelet count \<70,000/μL, INR \>1.5). 11. Concomitant advanced tumors or other severe organ diseases. 12. Suspected localized intestinal malignancy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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