Clinical trial · Interventional
Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus
NCT01301495CI-TRIAL-00018113withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants enrolled for more than 1 year.
Summary
Brief summary (as posted)
In this study, a newly designed and FDA approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed before and after treatment to confirm efficacy
Conditions
Conditions (1)
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HANAROSTENT TM covered Esophageal Stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HANAROSTENT covered Esophageal Stent
- interventionNames
- Device: HANAROSTENT TM covered Esophageal Stent
Primary outcomes (1)
- measure
- Palliation assessment based on Dysphagia Scores
- timeFrame
- 2 years
- description
- To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;
Secondary outcomes (1)
- measure
- Assessment of Complications and MD Anderson Dysphagia Score
- timeFrame
- 2-4 years
- description
- To determine whether it is non-inferior in efficacy and safety to the esophageal stents currently available at UVa with minimal complications and improvement of symptoms
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inoperable malignant obstruction of the esophageal or gastric cardia * Malignant fistula between the esophagus ans respiratory tree * Recurrent cancer after prior radiation Exclusion Criteria: * Patient unstable for endoscopic procedure * Previous esophageal stenting * Tumor growth within 2 cm of the upper esophageal sphincter * Pregnant women (self reported, no pregnancy test will be done per protocol)
References
Publications (0)
Data not yet available
No reference posted for this study.