BOUGIE CAP dilation for short benign esophageal strictures
Etude de Cohorte Sur l'Utilisation du Dispositif BOUGIE CAP™ Pour le Traitement Des sténoses œsophagiennes bénignes et Courtes
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 type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT07534800 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Standard balloon and bougie dilations have robust literature showing comparable effectiveness, while the BougieCap is a newer device with limited published outcome data.
Eligibility criteria
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 this trial is running
Lyon
- Hôpital Edouard Herriot — Lyon, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.