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
Not applicable · Testing stricture incision, balloon dilation and No Interventions · Sites not listed yet · Second Affiliated Hospital, Zhejiang University, School of Medicine
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing stricture incision (a procedure), balloon dilation (a procedure) and No Interventions (a procedure) as a possible treatment. Condition(s) listed: CD - Crohn's Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 16 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 2 more requirement(s). There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2026-03-01 (planned).
- Main results expected around 2027-12-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up (1 year)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | CD - Crohn's Disease |
| Lead sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Enrollment | 100 (estimated) |
| Start date | 2026-03-01 |
| Primary completion (est.) | 2027-12-31 |
| First posted | 2026-02-13 |
| Last updated | 2026-02-13 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07409376 |
Interventions
- stricture incision (Procedure)
Balloon-assisted enteroscopy-guided stricture incision versus balloon dilation - balloon dilation (Procedure)
Balloon-assisted enteroscopy-guided balloon dilation - No Interventions (Procedure)
No Intervention
Full eligibility criteria (from the record)
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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.