Clinical trial · Interventional
Removal of the Evolution® Esophageal Stent - Fully Covered
Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered
NCT01900691CI-TRIAL-00060813CLARITYcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Fistula | — | UNRESOLVED | — |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophageal Perforation | — | UNRESOLVED | — |
| Esophageal Stenosis | — | UNRESOLVED | — |
| Stents | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evolution® Esophageal Stent - Fully Covered | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Evolution® Esophageal Stent
- interventionNames
- Device: Evolution® Esophageal Stent - Fully Covered
Primary outcomes (1)
- measure
- Number of Patients With Successful Removal of Study Stent
- timeFrame
- 7 days to 6 months
- description
- 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 (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.