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NCT01647958 · ClinicalTrials.gov registry record · NA
The EndoGastric Solutions TEMPO Trial
A NA study, sponsored by EndoGastric Solutions.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
NCT01647958: Completed NA study, sponsored by EndoGastric Solutions.
NCT01647958 is a NA study that has completed, run by EndoGastric Solutions. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01647958, a NA study, has completed, sponsored by EndoGastric Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump Inhibitors (PPIs).
Primary Outcome
Elimination or clinically significant improvement in GERD symptoms, other than heartburn, refractory to PPI, evaluated by Reflux Symptom Index (RSI):9-item questionnaire measures atypical symptoms: hoarseness, throat clearing, excess throat mucus, dysphagia, cough. Scale for each item ranges from 0 (no problem) to 5 (severe), with max total score of 45, normality threshold of ≤13. Reflux Disease Questionnaire (RDQ):12-item questionnaire to assess frequency and severity of heartburn (4 items meas
Interventions
- DRUG PPI
- DEVICE EsophyX System with SerosaFuse fasteners
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2012-06-01 |
| Est. Completion | 2017-12-01 |
| Phase | NA |
What the finished NCT01647958 record still lists
NCT01647958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which PPI is the first listed.
NCT01647958 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01647958 about?
NCT01647958 is a clinical study titled "The EndoGastric Solutions TEMPO Trial". The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump...
What is the current status of trial NCT01647958?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2012-06-01. Estimated completion is 2017-12-01.
What interventions are being tested in trial NCT01647958?
The interventions under investigation include: PPI (DRUG), EsophyX System with SerosaFuse fasteners (DEVICE).
Who is sponsoring clinical trial NCT01647958?
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 NCT01647958's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 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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