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RecruitingNCT07534800BOUGIE CAP™Updated Apr 16, 2026

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

An observational study in Esophageal Strictures, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Esophageal Strictures

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Keywords

  • Esophageal strictures
  • BOUGIE CAP™
  • Ecological impact
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

200 patients with benign esophageal strictures diagnosed by endoscopy and confirmed by histology negative for malignancy and managed with BOUGIE CAP™ endoscopic dilation procedures will be recruited in participating research sites

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

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
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. The primary endpoint is the clinical success of esophageal strictures dilated by BOUGIE CAP™ at 6 months.

    Patients managed with monthly BOUGIE CAP™ procedures for esophageal strictures during a 6-month follow-up will be assessed. The success of the endoscopic dilation sequence is defined by the technical ability to achieve dilation to a diameter of at least 14mm

    Time frame: Patients managed with monthly BOUGIE CAP™ procedures for esophageal strictures will be evaluated during a 6-month follow-up

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT07534800
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Apr 16, 2026
Start date
Jan 4, 2026
Primary completion
Jun 1, 2026 (estimated)
Completion
Sep 1, 2029 (estimated)
Last update
Apr 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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