Gastroesophageal Reflux DiseaseRESPECTNCT01136980
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
A study testing TIF Transoral Fundoplication in people with Gastroesophageal Reflux Disease and Hiatal Hernia, run by EndoGastric Solutions at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Hiatal Hernia
- What is being tested?
- TIF Transoral Fundoplication
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2011to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- BMI > 35
- Hiatal hernia > 2 cm
- Esophagitis Los Angeles grade C or D
- Esophageal ulcer
- Esophageal stricture
- Esophageal motility disorder
Show all 16Show fewer
- 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 determination of anatomical presentation which in the opinion of the surgeon does not allow safe device introduction.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Northwestern University
Chicago, Illinois, 60611
Ohio State University Hospital
Columbus, Ohio, 43211
SurgOne PC
Englewood, Colorado, 80110
University of Texas, Health Science Center at Houston
Houston, Texas, 77401
Cedars Sinai Medical Center
Los Angeles, California, 90048
The Oregon Clinic
Portland, Oregon, 97210
Oregon Health and Science University
Portland, Oregon, 97239
Reston Surgical Associates
Reston, Virginia, 20190
University of Washington
Seattle, Washington, 98195
About this study
Official title: A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD Compared With Sham and Placebo Controls
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.
Read the detailed description
Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms, specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux Disease Questionnaire (RDQ).
Troublesome symptoms are those which occur a minimum of 2 days a week and are at least moderate in severity.
Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months and a clinically significant reduction in PPI usage at 12 months.
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Being tested
- TIF Transoral Fundoplication, Sham placebo procedure
- Keywords
- GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIF Transoral FundoplicationDevice
Also called TIF
A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions)
Sham placebo procedureOther
Also called Sham Procedure
The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus.
| Study group | Role | What they receive |
|---|---|---|
| Sham placebo procedure | Placebo comparator | Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ. Receives: Other: Sham placebo procedure |
| TIF Transoral Fundoplication | Active comparator | Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach. Receives: Device: TIF Transoral Fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
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.
Measured: 6 month follow up
Secondary outcomes (1)
Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score
DeMeester Score is a composite score taking into consideration reflux episodes, percentage of time pH is < 4 and others. DMS was first reported in 1974 by Johnson and DeMeester. It is a composite score that measures acid exposure during prolonged ambulatory pH monitoring. The parameters that constitute the score are:
- total number of episodes of reflux, - reflux is undesirable, therefore lower numbers are better, higher numbers are worse. Ideally there would be zero reflux episodes.
- % total time esophageal pH < 4, upright position and supine position, respectively - pH < 4 is undesirable, therefor lower percentages are better
- number of episodes longer than 5 minutes, - lower is better
- maximal reflux duration, (reflux is undesirable - lower is better
- total percentage of time with pH below 4 - below 4 is undesirable - lower is better
The composite score can be obtained by adding the scores calculated for each of the six components.
Measured: 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startApr 2011
- Primary completionApr 2015
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoGastric Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hunter, MD FACS, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136980
- Sponsor's protocol ID
- D01010
- Acronym
- RESPECT
- Status last verified
- Dec 2021
- First submitted
- 2 Jun 2010
- Last updated
- 3 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hunter JG, Kahrilas PJ, Bell RC, Wilson EB, Trad KS, Dolan JP, Perry KA, Oelschlager BK, Soper NJ, Snyder BE, Burch MA, Melvin WS, Reavis KM, Turgeon DG, Hungness ES, Diggs BS. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology. 2015 Feb;148(2):324-333.e5. doi: 10.1053/j.gastro.2014.10.009. Epub 2014 Oct 13.
PubMed 25448925
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD Compared With Sham and Placebo Controls
- ClinicalTrials.gov ID
- NCT01136980
- Acronym / sponsor ID
- RESPECT / D01010
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Keywords
- GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- EndoGastric SolutionsIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Posted 3 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms, specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux Disease Questionnaire (RDQ).
Troublesome symptoms are those which occur a minimum of 2 days a week and are at least moderate in severity.
Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months and a clinically significant reduction in PPI usage at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham placebo procedure | Placebo comparator | Other: Sham placebo procedureSham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ. |
| TIF Transoral Fundoplication | Active comparator | Device: TIF Transoral FundoplicationIntervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- BMI > 35
- Hiatal hernia > 2 cm
- Esophagitis Los Angeles grade C or D
- Esophageal ulcer
- Esophageal stricture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIF Transoral FundoplicationAlso: TIFA novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions) | Device | TIF Transoral Fundoplication |
| Sham placebo procedureAlso: Sham ProcedureThe Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus. | Other | Sham placebo procedure |
Primary outcome
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,
Time frame: 6 month follow up
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.
1 secondary outcome
Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score
Time frame: 6 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25448925Hunter JG, Kahrilas PJ, Bell RC, Wilson EB, Trad KS, Dolan JP, Perry KA, Oelschlager BK, Soper NJ, Snyder BE, Burch MA, Melvin WS, Reavis KM, Turgeon DG, Hungness ES, Diggs BS. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology. 2015 Feb;148(2):324-333.e5. doi: 10.1053/j.gastro.2014.10.009. Epub 2014 Oct 13.
- Individual participant dataSharing planned: No
Related trials for Gastroesophageal Reflux Disease
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hunter, MD FACS principal investigator
Oregon Health and Science University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIF Transoral Fundoplication in people with Gastroesophageal Reflux Disease and Hiatal Hernia, run by EndoGastric Solutions at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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, (time frame: 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01136980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.