Removal of the Evolution® Esophageal St… | Clinical Trial

Key information

Conditions

Esophageal Fistula Digestive System Diseases Digestive System Fistula Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Perforation Esophageal Stenosis Fistula Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stents Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evolution® Esophageal Stent - Fully Covered

Device

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

Primary outcomes

Number of Patients With Successful Removal of Study Stent

Time frame: 7 days to 6 months

The study design allowed for 130 patients to be enrolled to ensure that 58 patients had an attempted endoscopic stent removal between 7 days and 6 months in order to assess the primary measure as per sample size calculation. Therefore, the first 58 patients (malignant or benign lesions) with data submitted regarding attempted endoscopic stent removal are included in this outcome measure. Successful stent removal is one in which the study stent is completely removed from the patient during a single endoscopic procedure with the wire mesh integrity maintained such that the stent can be removed in one contiguous piece. Additionally, successful stent removal includes no tissue damage or hemorrhage visible during the retrieval procedure that is both related to the endoscopic stent removal and requires immediate treatment.

Secondary outcomes

Number of Patients With Benign Indications That Achieved Clinical Success

Time frame: 7 days

The rate of clinical success in patients with strictures that showed improvement or relief of dysphagia symptoms or a seal sufficient to enable oral intake in patients with fistulas, perforations, or leaks.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered

Acronym: CLARITY

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Jul 16, 2013
Registry last updated: Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed