Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Rare Diseases

Esophageal Neoplasms

Fistula

Constriction, Pathologic

Esophageal Fistula

Esophageal Perforation

Esophageal Stenosis

Pathological Conditions, Anatomical

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Digestive System Fistula

Esophageal Cancer

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

Evolution® Esophageal Stent - Fully Covered

John Vargo, M.D., M.P.H.

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.

Removal of the Evolution® Esophageal Stent - Fully Covered

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

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.

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.

Cook Group Incorporated

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

Evolution® Esophageal Stent

Age, Continuous

Sex: Female, Male

Ethnicity

Race/Ethnicity, Customized

Alan Saunders, MDR, RAC; Manager, Biostatistics

Number of Patients With Successful Removal of Study Stent

Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign fistulas, perforations or leaks with the intention of removal

Number of Patients With Benign Indications That Achieved Clinical Success

Overall Study

Spots Global Cancer Trial Database for esophageal fistula