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
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).
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
Exclusion Criteria:
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
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Hospices Civils de Lyon