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

NCT07534800 | Recruiting

• 2 other identifiers: 69HCL26-008325-5401
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Esophageal strictures; BOUGIE CAP™; Ecological impact

Outcome Measures

Primary Outcomes (1)

• 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

  Patients managed with monthly BOUGIE CAP™ procedures for esophageal strictures will be evaluated during a 6-month follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69437, France

RECRUITING

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: April 16, 2026
• Study Start: January 4, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)