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BOUGIE CAP Cohort Study, Esophageal Strictures

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Summary

The NIH ClinicalTrials.gov registry has posted an observational cohort study (NCT07534800) evaluating the BougieCap™ device (Ovesco Endoscopy AG) for treating benign and short esophageal strictures. The study aims to assess the device's performance and short-term effectiveness on dysphagia. This is an informational registration entry for an ongoing clinical study.

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What changed

The NIH ClinicalTrials.gov registry added a new observational cohort study (NCT07534800) examining the BougieCap™ device manufactured by Ovesco Endoscopy AG for endoscopic dilation of short benign esophageal strictures. The study will evaluate device performance and short-term effectiveness on dysphagia symptoms.\n\nHealthcare providers and clinical investigators conducting gastroenterology or gastrointestinal research may use this registry information to identify related studies, understand current research landscapes for esophageal stricture treatments, or consider patient referrals. The study does not create compliance obligations for manufacturers, providers, or patients—its purpose is research documentation and transparency under clinical trial registration requirements.

Archived snapshot

Apr 16, 2026

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← ClinicalTrials.gov Studies

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

Observational NCT07534800 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

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).

Conditions: Esophageal Strictures

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07534800

Who this affects

Applies to
Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Clinical research Medical device evaluation Gastrointestinal treatment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices

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