Removal of the Evolution® Esophageal Stent

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-12-10

Brief Summary

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The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.

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Detailed Description

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Conditions

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Esophageal Fistula Esophageal Neoplasms Esophageal Perforation Esophageal Stenosis Stents

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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Evolution® Esophageal Stent

Group Type EXPERIMENTAL

Evolution® Esophageal Stent - Fully Covered

Intervention Type DEVICE

Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Interventions

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Evolution® Esophageal Stent - Fully Covered

Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is diagnosed with benign or malignant stricture, fistula, perforation, or leak
* Physician plans to remove the stent within the duration of study follow-up

Exclusion Criteria

* Patient is \< 18 years of age
* Patient is unable or unwilling to provide written informed consent or comply with follow-up schedule
* Patient is pregnant, lactating, or planning on being pregnant within the next 6 months
* Patient is simultaneously participating in another investigational drug or device study
* Patient that is contraindicated to upper GI endoscopy and/or any procedure to be performed in conjunction with esophageal stent placement
* Patient has a known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No