WithdrawnNot Applicable

Balloon Dilation Methods for Benign Esophageal Stricture

Stopped: IRB closed due to slow accrual

United States0Started 2020-07-13

Plain-language summary

This is the first head to head, prospective, randomized, double-blind clinical trial comparing two different approaches of balloon dilation (standard versus progressive dilation) for benign esophageal strictures. A retrospective study on patients with benign esophageal strictures that underwent balloon dilation using the proposed technique found considerable symptomatic improvement in dysphagia. The proposed balloon dilation method is a novel approach that will require fewer sessions of dilation and use fewer balloon dilation catheters to achieve a maximum balloon diameter of 18mm and result in a significant symptomatic improvement.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * more than 18 years old * symptoms of dysphagia (difficulty swallowing) due to a benign esophageal stricture * willing to be randomized to either arm of the study. Exclusion Criteria: * less than 18 years of age * malignant esophageal stricture * stricture located in the gastrointestinal tract other than the esophagus * any benign or malignant stricture regardless of location in which the patient had previous mechanical or balloon dilation * diagnosis of achalasia * currently pregnant

What they're measuring

Change in Dysphagia

Timeframe: 1 year (at 1, 3, 6 and 12 months follow-up)

Number of endoscopic dilation sessions

Timeframe: 3 weeks

Number of balloons

Timeframe: 3 weeks

Trial details

NCT IDNCT04730076

SponsorSamuel H Mardini

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01

View on ClinicalTrials.gov More Esophageal Stricture trials