Esophageal Fully Covered Metal Stents in Caustic Strictures Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-11-30

Brief Summary

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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 strictures caused by caustic ingestion.

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Detailed Description

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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 strictures caused by caustic ingestion. Also to collect data in support of a hypothesis required to prospectively document the safety and effectiveness of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) compared to repeated Bougie Dilation for the treatment of refractory benign esophageal strictures caused by caustic ingestion.

Conditions

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Refractory Benign Esophageal Strictures Caused by Caustic Ingestion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metal Stent

The WallFlex™ Esophageal Fully Covered Metal Stent (FCMS)is being evaluated for the treatment of refractory benign esophageal strictures caused by caustic ingestion.

Group Type EXPERIMENTAL

Metal Stent (WallFlex™ Esophageal RX)

Intervention Type DEVICE

Interventions

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Metal Stent (WallFlex™ Esophageal RX)

Intervention Type DEVICE

Other Intervention Names

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WallFlex™ Esophageal RX Fully Covered Stent

Eligibility Criteria

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Inclusion Criteria

1. Availability of medical history pertaining to dysphagia score prior to and during the preceding SECSER.
2. Availability of patient history pertaining to weight prior to and at completion of SECSER.
3. Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment.
4. Single esophageal stricture or multiple esophageal stricture over a length \< 6 cm.
5. 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.
6. Refractory stricture defined as recurrence of stricture with associated dysphagia within 6 months after completion of SECSER.
7. Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
8. Unable to pass a standard endoscope (approximately 9.8 mm diameter).
9. Age 18 years or older.
10. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria

1. Stricture within 2 cm of the upper esophageal sphincter.
2. Concomitant Esophageal ulcerations.
3. Prior esophageal stent placements.
4. Concurrent gastric and/or duodenal obstruction.
5. Patients with prior full or partial gastrectomy.
6. Sensitivity to any components of the stent or delivery system.
7. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
8. Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes