RecruitingNCT07534800

Cohort Study on the Use of the BOUGIE CAP™ Device for the Treatment of Benign and Short Esophageal Strictures

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


Sponsor

Hospices Civils de Lyon

Enrollment

200 participants

Start Date

Jan 4, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • \- 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

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Hôpital Edouard Herriot

Lyon, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07534800


Related Trials