A Multi-Center, Prospective, Evaluation of the Use of a Fully Covered Metal Stent (FCMS) for the Treatment of Refractory Benign Esophageal Strictures caused by Ingestion

Boston Scientific0 个研究点目标入组 1 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Availability of medical history pertaining to dysphagia score prior to and during the preceeding 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 (approx. 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.

•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 investigatorâ??s ability to evaluate the patientâ??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.

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