Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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