Actively Recruiting

Age: 18Years +
All Genders
NCT07534800

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

Led by Hospices Civils de Lyon · Updated on 2026-04-16

200

Participants Needed

1

Research Sites

190 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patient objects to the collection or processing of their data
  • Patient does not want health data used after death
  • Patient under guardianship or curatorship
  • Pregnant woman
  • Malignant stenosis
  • Congenital stenosis
  • Associated fistula

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hôpital Edouard Herriot

Lyon, France, 69437

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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