CD - Crohn's DiseaseCD stenosisNCT07409376
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
A study testing stricture incision and balloon dilation in people with CD - Crohn's Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- CD - Crohn's Disease
- What is being tested?
- stricture incision and balloon dilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Deep ulcer in the stricture segment observed by enteroscopy, potentially involving the muscular layer.
- Presence of strictures in the esophagus, stomach, or duodenum.
- Presence of colorectal stricture or ileocecal valve stricture.
- Small bowel stricture complicated by abscess, fistula, or severe angulation.
- Patients with ≥3 small bowel strictures or stricture length ≥5 cm.
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- Strictures previously treated with stent placement, dilation, or incision but without sustained symptom-free remission for at least 1 year.
- Pregnancy or breastfeeding.
- Inability to undergo endoscopic treatment.
- Severe coagulation disorders (platelet count <70,000/μL, INR >1.5).
- Concomitant advanced tumors or other severe organ diseases.
- Suspected localized intestinal malignancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- CD - Crohn's Disease
- Being tested
- stricture incision, balloon dilation, No Interventions
- Keywords
- Crohn's Disease; balloon-assisted enteroscopy; stricture
- Medical subject headings
- Crohn Disease, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stricture incisionProcedure or surgery
Balloon-assisted enteroscopy-guided stricture incision versus balloon dilation
balloon dilationProcedure or surgery
Balloon-assisted enteroscopy-guided balloon dilation
No InterventionsProcedure or surgery
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | Sham comparator | Patients in this arm will not receive endoscopic interventional treatment for small bowel strictures and will be managed with standard medical therapy and clinical observation. Receives: Procedure: No Interventions |
| Balloon-assisted enteroscopy-guided balloon dilation | Experimental | Patients in this arm will undergo balloon dilation of small bowel strictures under balloon-assisted enteroscopy to relieve luminal narrowing. Receives: Procedure: balloon dilation |
| Balloon-assisted enteroscopy-guided stricture incision | Experimental | Patients in this arm will receive balloon-assisted enteroscopy-guided radial incision of small bowel strictures under direct endoscopic visualization. Receives: Procedure: stricture incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up
Percentage of patients who do not require any new therapeutic intervention, including endoscopic balloon dilation (EBD), endoscopic stricture incision (EST), or surgery, within 1 year after the initial procedure.
Measured: 1 year
Secondary outcomes (6)
Proportion of patients not requiring additional therapeutic interventions at 3-year follow-up
Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 3 years after the initial procedure.
Measured: 3 years
Proportion of patients not requiring additional therapeutic interventions at 5-year follow-up
Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 5 years after the initial procedure.
Measured: 5 years
Safety assessment of the two treatment methods
Evaluation of procedure-related complications, including postoperative bleeding, perforation, and any adverse events (AEs) or serious adverse events (SAEs) occurring within 2 months after the procedure.
Measured: Within 2 months post-procedure
Immediate technical success of the procedure
Assessment of successful passage of the endoscope through the stricture immediately after balloon dilation or stricture incision.
Measured: At the time of procedure
Symptom-free duration within 1 year post-procedure
Duration of symptom-free period within 1 year after the procedure, defined as a score ≤1 on the obstruction symptom assessment scale.
Measured: 1 year
Cost analysis of the two treatment methods
Comparative analysis of medical costs associated with balloon dilation versus stricture incision, including procedure, hospitalization, and follow-up expenses.
Measured: Up to 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD - Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Chen, PhD, Principal investigator, Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409376
- Sponsor's protocol ID
- 2025-1188
- Acronym
- CD stenosis
- Status last verified
- Dec 2025
- First submitted
- 9 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- CD stenosis / 2025-1188
- Conditions
- CD - Crohn's Disease
- Keywords
- Crohn's Disease; balloon-assisted enteroscopy; stricture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Intervention | Sham comparator | Procedure: No InterventionsPatients in this arm will not receive endoscopic interventional treatment for small bowel strictures and will be managed with standard medical therapy and clinical observation. |
| Balloon-assisted enteroscopy-guided balloon dilation | Experimental | Procedure: balloon dilationPatients in this arm will undergo balloon dilation of small bowel strictures under balloon-assisted enteroscopy to relieve luminal narrowing. |
| Balloon-assisted enteroscopy-guided stricture incision | Experimental | Procedure: stricture incisionPatients in this arm will receive balloon-assisted enteroscopy-guided radial incision of small bowel strictures under direct endoscopic visualization. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- Deep ulcer in the stricture segment observed by enteroscopy, potentially involving the muscular layer.
- Presence of strictures in the esophagus, stomach, or duodenum.
- Presence of colorectal stricture or ileocecal valve stricture.
- Small bowel stricture complicated by abscess, fistula, or severe angulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stricture incisionBalloon-assisted enteroscopy-guided stricture incision versus balloon dilation | Procedure or surgery | Balloon-assisted enteroscopy-guided stricture incision |
| balloon dilationBalloon-assisted enteroscopy-guided balloon dilation | Procedure or surgery | Balloon-assisted enteroscopy-guided balloon dilation |
| No InterventionsNo Intervention | Procedure or surgery | No Intervention |
Primary outcome
Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up
Time frame: 1 year
Percentage of patients who do not require any new therapeutic intervention, including endoscopic balloon dilation (EBD), endoscopic stricture incision (EST), or surgery, within 1 year after the initial procedure.
6 secondary outcomes
Proportion of patients not requiring additional therapeutic interventions at 3-year follow-up
Time frame: 3 years
Proportion of patients not requiring additional therapeutic interventions at 5-year follow-up
Time frame: 5 years
Safety assessment of the two treatment methods
Time frame: Within 2 months post-procedure
Immediate technical success of the procedure
Time frame: At the time of procedure
Symptom-free duration within 1 year post-procedure
Time frame: 1 year
Cost analysis of the two treatment methods
Time frame: Up to 1 year post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Chen, PhD principal investigator
Second Affiliated Hospital of Zhejiang University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing stricture incision and balloon dilation in people with CD - Crohn's Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shenglong Xia, Phd (+86-19857128950, xsl89@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.