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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 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 342-participant average among 24 other Gastroesophageal Reflux Disease trials with a reported enrollment target (62% lower). The trial reports 9 study locations across 8 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01136980
The ClinicalTrials.gov registry entry for NCT01136980 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 342-participant average among 24 other Gastroesophageal Reflux Disease trials with a reported enrollment target (62% lower). The listed sponsor is EndoGastric Solutions, which has 6 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 8 distinct geographic areas - top geographies include 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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