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NCT02396745 · ClinicalTrials.gov registry record · NA
TECR & ECM Placement for Esophageal High Grade Dysplasia
A NA study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT02396745: Clinical Trial NA study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
NCT02396745 is a NA study that was terminated before completion, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02396745, a NA study, was terminated before completion, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study will test the safety and effectiveness of esophageal transoral endoscopic circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential resection using ECM placement has been introduced as a less invasive, externally incision-less approach to treat patients with esophageal high grade dysplasia; a pre-cancerous condition. In this procedure, the entire length of diseased (abnormal) mucosa (esophagus lining) will be removed using an endoscope that will be inserted through the mouth. The ECM will be placed over the area that is being removed with a temporary, expandable stent to prevent narrowing of the esophagus. The stent is being used to hold the ECM in place as the body begins the healing process. This stent will be removed 14 days (±4 days) after this procedure. Follow-up esophagogastroduodenoscopies (EGD), barium swallow x-ray tests, and questionnaires will take place for 12 months following the procedure. The result of this study may help doctors determine if this procedure would be a more effective treatment option for HGD in the future.
Primary Outcome
To evaluate incidence of stricture formation requiring dilation (≥30% luminal diameter reduction with dysphagia) following TECR with ECM placement. Evidence of stricture formation will be confirmed endoscopically at 2 weeks, and endoscopically and through barium swallow at Month 1, Month 3, Month 6, Month 9, and Month 12 post procedure, and the proportion of subjects with and without stricture formation at the trial endpoints will be compared to historical data.
Interventions
- DEVICE Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex))
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-01-25 |
| Est. Completion | 2018-03-22 |
| Phase | NA |
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)34 total trials
Why NCT02396745 stopped before completion
NCT02396745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)) is the first listed.
NCT02396745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02396745 about?
NCT02396745 is a clinical study titled "TECR & ECM Placement for Esophageal High Grade Dysplasia". This study will test the safety and effectiveness of esophageal transoral endoscopic circumferential resection (TECR) using an extracellular matrix (ECM) placement to treat Barrett's esophagus in patients with high-grade dysplasia (HGD). Endoscopic circumferential resection using ECM placement has b...
What is the current status of trial NCT02396745?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2016-01-25. Estimated completion is 2018-03-22.
What interventions are being tested in trial NCT02396745?
The interventions under investigation include: Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex)) (DEVICE).
Who is sponsoring clinical trial NCT02396745?
This trial is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02396745's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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