Cohort Study on the Use of the BOUGIE CAP™ Device for the Treatment of Benign and Short Esophageal Strictures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Esophageal Strictures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Etude de Cohorte Sur l'Utilisation du Dispositif BOUGIE CAP™ Pour le Traitement Des sténoses œsophagiennes bénignes et Courtes
Overview
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).
Primary outcome measures
- The primary endpoint is the clinical success of esophageal strictures dilated by BOUGIE CAP™ at 6 months. [Time frame: Patients managed with monthly BOUGIE CAP™ procedures for esophageal strictures will be evaluated during a 6-month follow-up]
Eligibility criteria
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
- \- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Edouard Herriot — Lyon
Identifiers
NCT: NCT07534800 · 69HCL26-0083 · 25-5401