Esophageal Fully Covered Metal Stents in Caustic Strictures Study (NCT01899300) | Clinical Trial Compass
CompletedNot Applicable
Esophageal Fully Covered Metal Stents in Caustic Strictures Study
India1 participantsStarted 2015-03
Plain-language summary
The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlexâ„¢ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion.
Who can participate
Age range18 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
✓. Availability of medical history pertaining to dysphagia score prior to and during the preceding SECSER.
✓. Availability of patient history pertaining to weight prior to and at completion of SECSER.
✓. Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment.
✓. Single esophageal stricture or multiple esophageal stricture over a length \< 6 cm.
✓. Having completed the SECSER consisting of 3 dilations intended to reach 15 mm each, separated by 2 weeks, followed by 3 dilations intended to reach 15 mm each with steroid injections, separated by 2 weeks. The dilations may be performed using Bougie or balloon dilation at the discretion of the investigator.
✓. Refractory stricture defined as recurrence of stricture with associated dysphagia within 6 months after completion of SECSER.
✓. Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
✓. Unable to pass a standard endoscope (approximately 9.8 mm diameter).
Exclusion criteria
✕. Stricture within 2 cm of the upper esophageal sphincter.
✕. Concomitant Esophageal ulcerations.
✕. Prior esophageal stent placements.
What they're measuring
1
Clinical Success
Timeframe: From stent placement on day 0 to 6 months after stent removal