NCT07534800 Cohort Study on the Use of the BOUGIE CAP™ Device for the Treatment of Benign and Short Esophageal Strictures
| NCT ID | NCT07534800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Esophageal Strictures |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-01-04 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-01-04 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Benign esophageal strictures are a common condition with multiple and varied causes. Esophageal strictures are manifested by the appearance of dysphagia, usually when the reduction in the esophageal lumen is greater than 50%. Malnutrition and aspiration pneumonia can also occur. Quality of life can thus be significantly impaired. To date, there are multiple techniques for treating strictures. Dilation (hydrostatic or bougie) is the historical first-line treatment. The effectiveness of the 2 historical dilation methods (balloon vs bougie) is comparable, with no difference in terms of adverse effects, with robust literature on the subject. There is a new device called the BougieCap™ (Ovesco Endoscopy AG, Tubingen, Germany). It is a short, tapered, conical-shaped transparent cap that attaches to the end of the endoscope. This cap allows the treatment of short strictures, with direct visualization during dilation. The results of this research will be used to better evaluate the performance of the Bougie Cap™ in the endoscopic dilation of short benign esophageal strictures as well as its short-term effectiveness on dysphagia. Another advantage of this device, particularly compared to older techniques, is its ecological potential (lower packaging weight).
Eligibility Criteria
Inclusion Criteria: * Patient aged 18 or over * Benign esophageal stricture diagnosed by endoscopy and confirmed by histology negative for malignancy * Short stenosis * With dysphagia * With indication for first-line endoscopic treatment Exclusion Criteria: * \- A patient objects to the collection or processing of their data. * The patient did not want his health data to be used after his death. * Patient under guardianship, curatorship * Pregnant woman * Malignant stenosis * Congenital stenosis * Associated fistula
Frequently Asked Questions
Who can join the NCT07534800 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Strictures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07534800 currently recruiting?
Yes, NCT07534800 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospices Civils de Lyon to inquire about joining.
Where is the NCT07534800 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT07534800 clinical trial?
NCT07534800 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 200 participants.