Actively Recruiting

Age: 18Years +
All Genders
ID07534800

Cohort Study on Using the BougieCap Device for Treating Benign, Short Esophageal Strictures

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

200

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Benign esophageal strictures are a common problem caused by various factors, leading to difficulty swallowing when the esophagus narrows significantly. This condition can cause malnutrition and lung infections, greatly affecting quality of life. Researchers are observing how a new device called the BougieCap, which attaches to an endoscope, performs in treating short benign esophageal strictures and its effectiveness in improving swallowing. The BougieCap is a transparent, tapered cap that allows doctors to see directly while dilating the esophagus, potentially offering an advantage over traditional balloon or bougie dilation methods. The study will follow patients who receive monthly dilation treatments using the BougieCap over six months to assess clinical success. Participants will be monitored for six months with regular evaluations during this period. The main measure is how well the esophageal strictures respond to treatment as assessed by clinical success at six months. The study also considers the ecological benefits of the device due to its lighter packaging. Participants will undergo endoscopic procedures and follow-up visits to track treatment effects and safety.

CONDITIONS

Brief 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
  • Diagnosis of benign esophageal stricture confirmed by endoscopy and histology showing no cancer
  • Presence of short esophageal stenosis
  • Experience of difficulty swallowing (dysphagia)
  • Indicated for first-line endoscopic treatment
Not Eligible

You will not qualify if you...

  • Patient objects to collection or use of their data
  • Patient does not want health data used after death
  • Patient under legal guardianship or curatorship
  • Pregnant women
  • Malignant esophageal stenosis
  • Congenital stenosis
  • Presence of associated fistula

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 6 months

Participants undergo monthly BOUGIE CAP™ procedures for esophageal strictures as part of routine care.

Monthly visits for up to 6 months

Long-term Monitoring

Duration - Up to 6 months follow-up

Participants are evaluated for clinical success and followed up after the implementation period.

Monthly visits during follow-up

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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