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NCT02159898 · ClinicalTrials.gov registry record · NA
EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX
A NA study of Malignant Esophageal Strictures, sponsored by Merit Medical Systems.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 7
- Study locations
NCT02159898: Completed NA study of Malignant Esophageal Strictures, sponsored by Merit Medical Systems.
NCT02159898 is a NA study of Malignant Esophageal Strictures that has completed, run by Merit Medical Systems. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02159898, a NA study of Malignant Esophageal Strictures, has completed, sponsored by Merit Medical Systems.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a prospective, single blinded, randomized study of EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve for the treatment of malignant strictures of the lower esophagus. The purpose of this study is to evaluate improvement of dysphagia due to esophageal stricture with EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).
Primary Outcome
The primary endpoint is to evaluate improvement of dysphagia due to esophageal strictures at 2 weeks following treatment. Scale: 0 = able to eat normal diet / no dysphagia. 1. = able to swallow some solid foods 2. = able to swallow only semi solid foods 3. = able to swallow liquids only 4. = unable to swallow anything / total dysphagia
Conditions Studied
Interventions
- DEVICE EndoMAXX Endoluminal Valve Technology (EVT)
- DEVICE EndoMAXX
Study Locations (7)
Colorado
- University of Colorado Denver - Aurora
Florida
- University of Florida - Gainesville
Indiana
- Indiana University - Indianapolis
Minnesota
- Mayo Clinic - Rochester
New York
- Weill Cornell Medical College - New York
Pennsylvania
- Geisinger Medical Center - Danville
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-12 |
| Phase | NA |
What the finished NCT02159898 record still lists
NCT02159898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Malignant Esophageal Strictures appearing as the primary indexed condition, and to 2 interventions - of which EndoMAXX Endoluminal Valve Technology (EVT) is the first listed.
NCT02159898 lists 7 locations in 7 states (Colorado, Florida, Indiana).
Frequently Asked Questions
What is clinical trial NCT02159898 about?
NCT02159898 is a clinical study titled "EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX". This is a prospective, single blinded, randomized study of EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve for the treatment of malignant strictures of the lower esophagus. The purpose of this study is to evaluate improvement of dysphagia due to esophageal stric...
What is the current status of trial NCT02159898?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2015-01. Estimated completion is 2016-12.
What conditions does trial NCT02159898 study?
This clinical trial studies the following conditions: Malignant Esophageal Strictures.
What interventions are being tested in trial NCT02159898?
The interventions under investigation include: EndoMAXX Endoluminal Valve Technology (EVT) (DEVICE), EndoMAXX (DEVICE).
Who is sponsoring clinical trial NCT02159898?
This trial is sponsored by Merit Medical Systems, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02159898 being conducted?
This trial has 7 study locations across Colorado, Florida, Indiana, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02159898's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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