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NCT01327963 · ClinicalTrials.gov registry record · NA
Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
A NA study, sponsored by EndoGastric Solutions.
- Terminated
- Registry status
- NA
- Development phase
- 110
- Enrollment target
NCT01327963: Clinical Trial NA study, sponsored by EndoGastric Solutions.
NCT01327963 is a NA study that was terminated before completion, run by EndoGastric Solutions. The registered enrollment target is 110 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01327963, a NA study, was terminated before completion, sponsored by EndoGastric Solutions.
- TERMINATED
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
Study Summary
The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.
Primary Outcome
Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of \<18) and Reflux Symptom Index (RSI measures atypical laryngopha
Interventions
- DEVICE Transoral Incisionless Fundoplication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-02 |
| Phase | NA |
Why NCT01327963 stopped before completion
NCT01327963 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Transoral Incisionless Fundoplication is the first listed.
NCT01327963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01327963 about?
NCT01327963 is a clinical study titled "Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study". The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the Uni...
What is the current status of trial NCT01327963?
This trial is currently terminated. It is a NA study. The enrollment target is 110 participants. The study started on 2010-09. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01327963?
The interventions under investigation include: Transoral Incisionless Fundoplication (DEVICE).
Who is sponsoring clinical trial NCT01327963?
This trial is sponsored by EndoGastric Solutions, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01327963's enrollment target sits among peer trials
110 816th of 2000 higher than 1,176 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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