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NCT01136980 · ClinicalTrials.gov registry record · NA
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
A NA study of Gastroesophageal Reflux Disease and Hiatal Hernia, sponsored by EndoGastric Solutions.
- Completed
- Registry status
- NA
- Development phase
- 129
- Enrollment target
- 9
- Study locations
NCT01136980: Completed NA study of Gastroesophageal Reflux Disease and Hiatal Hernia, sponsored by EndoGastric Solutions.
NCT01136980 is a NA study of Gastroesophageal Reflux Disease and Hiatal Hernia that has completed, run by EndoGastric Solutions. The registered enrollment target is 129 participants, below the 351-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (63% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01136980, a NA study of Gastroesophageal Reflux Disease and Hiatal Hernia, has completed, sponsored by EndoGastric Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 129 participants
- Enrollment target
- 9
- Study locations
Study Summary
The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo controls.
Primary Outcome
Primary efficacy Hypothesis 1: At 6-month follow-up, the proportion of Transesophageal Incisionless Fundoplication (TIF)2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI (Proton Pump Inhibitor) treatment group.
Conditions Studied
Interventions
- DEVICE TIF Transoral Fundoplication
- OTHER Sham placebo procedure
Study Locations (9)
Oregon
- The Oregon Clinic - Portland
- Oregon Health and Science University - Portland
California
- Cedars Sinai Medical Center - Los Angeles
Colorado
- SurgOne PC - Englewood
Illinois
- Northwestern University - Chicago
Ohio
- Ohio State University Hospital - Columbus
Texas
- University of Texas, Health Science Center at Houston - Houston
Virginia
- Reston Surgical Associates - Reston
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2011-04 |
| Est. Completion | 2018-03 |
| Phase | NA |
What the finished NCT01136980 record still lists
NCT01136980 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 351-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (63% lower).
The record links to 2 conditions, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 2 interventions - of which TIF Transoral Fundoplication is the first listed.
NCT01136980 lists 9 locations in 8 states (Oregon, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT01136980 about?
NCT01136980 is a clinical study titled "Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study". The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo control...
What is the current status of trial NCT01136980?
This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2011-04. Estimated completion is 2018-03.
What conditions does trial NCT01136980 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux Disease, Hiatal Hernia.
What interventions are being tested in trial NCT01136980?
The interventions under investigation include: TIF Transoral Fundoplication (DEVICE), Sham placebo procedure (OTHER).
Who is sponsoring clinical trial NCT01136980?
This trial is sponsored by EndoGastric Solutions, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01136980 being conducted?
This trial has 9 study locations across California, Colorado, Illinois, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01136980's enrollment target sits among peer trials
129 10th of 25 higher than 16 of 25 other Gastroesophageal Reflux Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux Disease 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.
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