Trial Outcomes & Findings for Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study (NCT NCT01136980)
NCT ID: NCT01136980
Last Updated: 2021-12-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
6 month follow up
Results posted on
2021-12-03
Participant Flow
Participant milestones
| Measure |
Sham Placebo Procedure
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.
Sham placebo 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.
|
TIF Transoral Fundoplication
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.
TIF Transoral Fundoplication: 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)
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
87
|
|
Overall Study
COMPLETED
|
28
|
76
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
Baseline characteristics by cohort
| Measure |
Sham Placebo Procedure
n=42 Participants
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.
Sham placebo 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.
|
TIF Transoral Fundoplication
n=87 Participants
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.
TIF Transoral Fundoplication: 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)
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
52 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
87 participants
n=7 Participants
|
129 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 month follow upPopulation: Patients completing 6 month post-procedure 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.
Outcome measures
| Measure |
Sham Placebo Procedure
n=28 Participants
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.
Sham placebo 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.
|
TIF Transoral Fundoplication
n=76 Participants
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.
TIF Transoral Fundoplication: 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)
|
|---|---|---|
|
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,
|
17 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 6 months post procedurePopulation: Patients that completed 6 month follow-up. NOTE: greater than 14.72 is considered abnormal, 14.72-50 is regarded as mild GERD, 51-100 is regarded as moderate GERD, and greater than 100 is regarded as severe GERD.
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: 1. 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. 2. % total time esophageal pH \< 4, upright position and supine position, respectively - pH \< 4 is undesirable, therefor lower percentages are better 3. number of episodes longer than 5 minutes, - lower is better 4. maximal reflux duration, (reflux is undesirable - lower is better 5. 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.
Outcome measures
| Measure |
Sham Placebo Procedure
n=28 Participants
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.
Sham placebo 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.
|
TIF Transoral Fundoplication
n=76 Participants
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.
TIF Transoral Fundoplication: 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)
|
|---|---|---|
|
Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score
Pre-Procedure DeMeester Score
|
30.9 Composite DeMeester Score
Interval 14.0 to 50.0
|
33.6 Composite DeMeester Score
Interval 14.0 to 110.0
|
|
Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score
6 month post-procedure DeMeester Score
|
32.7 Composite DeMeester Score
Interval 1.0 to 65.0
|
23.9 Composite DeMeester Score
Interval 0.0 to 80.0
|
Adverse Events
Sham Placebo Procedure
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
TIF Transoral Fundoplication
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham Placebo Procedure
n=42 participants at risk
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.
Sham placebo 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.
|
TIF Transoral Fundoplication
n=87 participants at risk
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.
TIF Transoral Fundoplication: 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)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1 • 6 months
|
0.00%
0/87 • 6 months
|
|
Gastrointestinal disorders
Temporary epigastric /abdominal pain
|
0.00%
0/42 • 6 months
|
1.1%
1/87 • Number of events 1 • 6 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/42 • 6 months
|
1.1%
1/87 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/42 • 6 months
|
1.1%
1/87 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Sham Placebo Procedure
n=42 participants at risk
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.
Sham placebo 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.
|
TIF Transoral Fundoplication
n=87 participants at risk
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.
TIF Transoral Fundoplication: 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)
|
|---|---|---|
|
Gastrointestinal disorders
Temporary epigastric / abdominal pain
|
0.00%
0/42 • 6 months
|
1.1%
1/87 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/42 • 6 months
|
2.3%
2/87 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42 • 6 months
|
1.1%
1/87 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place