Clinical trial Recruiting at 1 site Observational Ages 18 and up

BOUGIE CAP dilation for short benign esophageal strictures

Official title: Etude de Cohorte Sur l'Utilisation du Dispositif BOUGIE CAP™ Pour le Traitement Des sténoses œsophagiennes bénignes et Courtes

Run by Hospices Civils de Lyon · NCT07534800 · Data updated 2026-11-12

This research will test whether the BOUGIE CAP device can safely and effectively widen short benign esophageal strictures in adults who have trouble swallowing.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorHospices Civils de Lyon
Academic / other
Locations1 site (Lyon)
StatusRecruiting
StartedJanuary 4, 2026
Main results expectedJune 1, 2026
Study endsSeptember 1, 2029
Registry record updatedApril 16, 2026
Trial IDNCT07534800 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 or older with short benign esophageal strictures confirmed by endoscopy and histology, presenting with dysphagia and indicated for first-line endoscopic treatment are the ideal candidates.

Probably not a fit

Patients with malignant or congenital strictures, associated fistula, long strictures, pregnant individuals, or those unable or unwilling to consent or permit data use are unlikely to be eligible or to benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort enrolls adults with endoscopy- and biopsy-confirmed short benign esophageal strictures and dysphagia who are candidates for first-line endoscopic dilation. The BougieCap is a short, tapered transparent cap that attaches to the endoscope and permits direct visualization during bougie-style dilation. Study staff will document procedural performance, symptom improvement, complications, and need for repeat dilations. Collected data will be used to better characterize the device's safety and practical performance in routine clinical use.

Why it matters

Potential benefit: If successful, the BougieCap could offer a visually guided dilation option that improves swallowing outcomes or reduces complications and repeat procedures for patients with short benign strictures.

How similar studies have gone: Standard balloon and bougie dilations have robust literature showing comparable effectiveness, while the BougieCap is a newer device with limited published outcome data.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Hôpital Edouard Herriot
    Lyon, France
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.