Status:
COMPLETED
Esophageal Fully Covered Metal Stents in Caustic Strictures Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Refractory Benign Esophageal Strictures Caused by Caustic Ingestion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal ...
Detailed Description
The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal ...
Eligibility Criteria
Inclusion
- 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).
- Age 18 years or older.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion
- Stricture within 2 cm of the upper esophageal sphincter.
- Concomitant Esophageal ulcerations.
- Prior esophageal stent placements.
- Concurrent gastric and/or duodenal obstruction.
- Patients with prior full or partial gastrectomy.
- Sensitivity to any components of the stent or delivery system.
- Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
- Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01899300
Start Date
March 1 2015
End Date
November 1 2015
Last Update
February 12 2021
Active Locations (2)
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1
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
2
Asian Institute of Gastroenterology
Hyderabad, India, 500082