CompletedNot Applicable

Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study

United States129 participantsStarted 2011-04

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-80 years * Dependent upon daily PPIs for \> 6 months * Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of omeprazole or equivalent. Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days a week and are at least moderate in severity. * Abnormal ambulatory pH study off PPI therapy for 7 days. * Normal or near normal esophageal motility (by manometry) * Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should not exceed 2.5 cm * Patient willing to cooperate with post-operative dietary recommendations and assessment tests * Signed informed consent Exclusion Criteria: * BMI \> 35 * Hiatal hernia \> 2 cm * Esophagitis Los Angeles grade C or D * Esophageal ulcer * Esophageal stricture * Esophageal motility disorder * Pregnancy or plans for pregnancy in the next 12 months (in females) * Immunosuppression * ASA \> 2 * Portal hypertension and/or varices * History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis * Active gastro-duodenal ulcer disease * Gastric outlet obstruction or stenosis * Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment * Coagulation disorders * Interprocedural det…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With a Clinically Significant Reduction in Gastroesophageal Reflux Disease (GERD) Symptoms (Specifically "Troublesome" Regurgitation With or Without Heartburn as Assessed by the RDQ Per the Montreal Consensus Definition,

Timeframe: 6 month follow up

Trial details

NCT IDNCT01136980

SponsorEndoGastric Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-04

Results submitted2020-11-12

View on ClinicalTrials.gov More Gastroesophageal Reflux Disease trials