Trial Outcomes & Findings for The EndoGastric Solutions TEMPO Trial (NCT NCT01647958)

Results Overview

Elimination or clinically significant improvement in GERD symptoms, other than heartburn, refractory to PPI, evaluated by Reflux Symptom Index (RSI):9-item questionnaire measures atypical symptoms: hoarseness, throat clearing, excess throat mucus, dysphagia, cough. Scale for each item ranges from 0 (no problem) to 5 (severe), with max total score of 45, normality threshold of ≤13. Reflux Disease Questionnaire (RDQ):12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Scores calculated as mean of item responses with higher scores indicating more severe or frequent symptoms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

65 participants

Primary outcome timeframe

6 months

Results posted on

2020-11-23

Participant Flow

Patients were recruited from seven U.S. hospitals.

65 patients randomized: 41 treatment, 24 control. 39 and 21 respectively, were completed. Control-arm patients offered Crossover to TIF following 6 mo. follow-up visit. 21 control-arm patients crossed over to TIF procedure after 6-month follow-up. Note: 6 mo. difference between Crossover and Treatment patient post-hoc results. Extended Results Phase (3 and 5yr follow-up) participants are placed in a single cohort of Treatment + Control arm patients.

Participant milestones

Participant milestones
Measure	Treatment Arm Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Initial Study STARTED	41	24
Initial Study COMPLETED	39	21
Initial Study NOT COMPLETED	2	3
Continuation Phase STARTED	39	21
Continuation Phase COMPLETED	0	21
Continuation Phase NOT COMPLETED	39	0
Extended Follow-up Phase STARTED	60	0
Extended Follow-up Phase COMPLETED	52	0
Extended Follow-up Phase NOT COMPLETED	8	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Initial Study Lost to Follow-up	2	3
Continuation Phase treatment received during Overall Study	39	0
Extended Follow-up Phase Lost to Follow-up	8	0

Baseline Characteristics

The EndoGastric Solutions TEMPO Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=39 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=21 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	21 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	54.8 years n=5 Participants	50.1 years n=7 Participants	53.16 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	8 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants	21 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Elimination or clinically significant improvement in GERD symptoms, other than heartburn, refractory to PPI, evaluated by Reflux Symptom Index (RSI):9-item questionnaire measures atypical symptoms: hoarseness, throat clearing, excess throat mucus, dysphagia, cough. Scale for each item ranges from 0 (no problem) to 5 (severe), with max total score of 45, normality threshold of ≤13. Reflux Disease Questionnaire (RDQ):12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Scores calculated as mean of item responses with higher scores indicating more severe or frequent symptoms.

Outcome measures

Outcome measures
Measure	Treatment Arm n=39 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=21 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants Reporting GERD (Gastroesophageal Reflux Disease) Symptom Elimination or Clinically Significant Improvement Evaluated by RSI (Reflux Symptom Index) and RDQ (Reflux Disease Questionnaire).	24 Participants	1 Participants

PRIMARY outcome

Timeframe: 6 months

Elimination or clinically significant improvement in troublesome regurgitation refractory to PPIs as evaluated by the disease-specific and validated instrument, Reflux Disease Questionnaire (RDQ):12-item questionnaire assesses frequency and severity of heartburn (4 items measure frequency and severity of pain and burning behind breastbone), regurgitation (4 items measuring the frequency and severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses range from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Patient's score is calculated as the mean of item responses with higher scores indicating more severe or frequent symptoms. A frequency score of 3 or more and severity score of 2 or more for the regurgitation questions were required to meet the Montreal consensus criteria for troublesome regurgitation.

Outcome measures

Outcome measures
Measure	Treatment Arm n=30 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=18 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment	29 Participants	9 Participants

SECONDARY outcome

Timeframe: 6 Months

Elimination of daily bothersome GERD (Gastro Esophageal Reflux Disease) HRQL symptoms, using RDQ (Reflux Disease Questionnaire), RSI (Reflux Symptom Index) and as measured by complete discontinuation of PPI (Proton Pump Inhibitors) therapy at 6-month follow-up.

Outcome measures

Outcome measures
Measure	Treatment Arm n=39 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=21 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With Complete PPI Discontinuation Assessed Using Validated Questionnaires and Participant-reported Discontinuation	35 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 Months

Assessment of esophageal acid exposure with normal defined as pH\<4 in less than 5.3% total time exposure, using 48hr pH metry, with patients off PPIs for at least 7 days

Outcome measures

Outcome measures
Measure	Treatment Arm n=39 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=21 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With Normalization of Esophageal Acid Exposure Assessed Using 48-hour pH Metry	21 Participants	11 Participants

SECONDARY outcome

Timeframe: 6 months

Esophagitis graded using the LA grading system through endoscopic visualization. Data entered represents study participants with complete healing or reduction in reflux esophagitis compared to baseline results. Note that Control arm patients were assessed while on PPIs. LA grades are A, B, C, D, with A being the least severe. Grade D was an exclusion criteria. Normal has no associated grade.

Outcome measures

Outcome measures
Measure	Treatment Arm n=20 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=13 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With Complete Healing or Reduction of Reflux Esophagitis, Assessed by EGD Using Los Angeles (LA) Grading	18 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Elimination of daily bothersome heartburn as measured by GERD-HRQL (Gastro Esophageal Reflux Disease - Health-Related Quality of Life) questionnaire. GERD-HRQL is a validated questionnaire used to assess typical GERD symptoms by measuring 10 items on the visual analog scale ranging from 0 (no symptoms) to 5 (worst symptoms). A higher total GERD-HRQL score (range from 0 to 50) indicates more severe GERD. Note Control Arm patients are assessed while on standard daily dose of PPIs.

Outcome measures

Outcome measures
Measure	Treatment Arm n=31 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=16 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With Elimination of Daily Troublesome Heartburn Assessed Using a Validated Questionnaire	28 Participants	2 Participants

POST_HOC outcome

Timeframe: 12 months

Assess number of patients reporting global elimination of troublesome regurgitation and atypical symptoms using Reflux Disease Questionnaire (RDQ), a 12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity, and Reflux Symptom Index (RSI), a 9-item questionnaire to assess atypical symptoms: hoarseness, throat clearing, excess throat mucus, dysphagia, cough. Scale for each item ranges from 0 (no problem) to 5 (severe), with max score of 45, normality threshold of ≤13. Scores calculated as mean of item responses with higher scores indicating more severe or frequent symptoms.

Outcome measures

Outcome measures
Measure	Treatment Arm n=39 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=20 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With GERD Symptom Control Following TIF and Crossover TIF, Assessed by Validated Questionnaires (Primary Endpoint)	30 Participants	13 Participants

POST_HOC outcome

Timeframe: 12 months

Assessment of the number of patients reporting elimination of troublesome regurgitation using the validated Reflux Disease Questionnaire (RDQ), a 12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity A frequency score of three or more and severity score of two or more for the regurgitation questions were required to meet the Montreal consensus criteria for troublesome regurgitation. The lower the score the better the outcome. (Crossover patients are 6-months post TIF.)

Outcome measures

Outcome measures
Measure	Treatment Arm n=30 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=9 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants Reporting Elimination of Troublesome Regurgitation Assessed Using a Validated Questionnaire (Primary Endpoint)	28 Participants	6 Participants

POST_HOC outcome

Timeframe: 12 months

Assessment of number of participants reporting healed esophagitis after TIF using EGD and LA grading system. Treatment arm patients assessed at 12 month post TIF and Control arm patients are at 6 month post Crossover TIF (12 month post randomization). LA grading A, B, C, D, with A the least severe esophagitis. No grade listed is "Normal". Grade D is an exclusion criteria.

Outcome measures

Outcome measures
Measure	Treatment Arm n=19 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=13 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With Healing of Esophagitis After TIF and Crossover TIF (Secondary Endpoint)	19 Participants	11 Participants

POST_HOC outcome

Timeframe: 12 months

Assessment of esophageal acid exposure with normal defined as pH\<4 in less than 5.3% total time exposure, using 48hr pH metry, with patients off PPIs for at least 7 days.

Outcome measures

Outcome measures
Measure	Treatment Arm n=38 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=21 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With Normal Esophageal Acid Exposure Assessed Post-TIF and Post-Crossover TIF (Secondary Endpoint)	17 Participants	7 Participants

POST_HOC outcome

Timeframe: 12 months

Number of patients reporting complete cessation of daily PPI therapy at 12 months post TIF and 6 months post Crossover TIF. This is patient-reported.

Outcome measures

Outcome measures
Measure	Treatment Arm n=39 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=21 Participants Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants Completely Off Daily PPIs Following TIF and Crossover TIF (Secondary Endpoint)	32 Participants	15 Participants

POST_HOC outcome

Timeframe: 36 months

Population: Extended Follow-up Phase will place all patients into one cohort, combining Treatment and Control arm patients. All become "Treatment" patients so Control arm number of participants becomes 0.

Assessment of the number of patients reporting elimination of troublesome regurgitation using the validated Reflux Disease Questionnaire (RDQ), a 12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measure frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency and severity of pain or burning in upper stomach). Responses from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. A frequency score of three or more and severity score of two or more for the regurgitation questions were required to meet the Montreal consensus criteria for troublesome regurgitation. The cohort of patients reported includes Treatment arm patients and Crossover patients combined as one group. Crossover patients included in the cohort are 30 months post TIF.

Outcome measures

Outcome measures
Measure	Treatment Arm n=41 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants Reporting Elimination of Troublesome Regurgitation Assessed Using a Validated Questionnaire (Primary Endpoint)	37 Participants	0 Participants

POST_HOC outcome

Timeframe: 36 months

Population: Control/Crossover arm patients are included in the overall number of participants analyzed under the Treatment arm section, so Control arm number will be 0.

Assessment of atypical GERD symptoms (symptoms other than heartburn) using validated Reflux Symptom Index (RSI), a 9 item questionnaire with a 0-5 score for each, for a total of 45, and a normality threshold of ≤13. The lower the score the better the outcome. Control/Crossover arm patients included in this cohort are at 30 months post TIF.

Outcome measures

Outcome measures
Measure	Treatment Arm n=48 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Study Participants Reporting Elimination of All Troublesome Atypical GERD Symptoms Assessed by Reflux Symptom Index (RSI) (Primary Endpoint)	42 Participants	0 Participants

POST_HOC outcome

Timeframe: 36 months

Population: All patients are reported as one cohort, under the Treatment arm. Control arm number of participants analyzed will be 0. All are included in Overall Number in Treatment arm section.

Assessment of esophageal acid exposure with normal defined as pH\<4 in less than 5.3% total time exposure, using 48hr pH metry, with patients off PPIs for at least 7 days. Note that patients originally in the Control/Crossover arm are at 30 months post TIF at this follow up period. Treatment and Control/Crossover patients are reported as a single cohort.

Outcome measures

Outcome measures
Measure	Treatment Arm n=40 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With pH Normalization at 3-year Follow-up (Secondary Endpoint)	16 Participants	0 Participants

POST_HOC outcome

Timeframe: 36 months

Population: Treatment and Control/Crossover patients are reported as a single cohort at this follow-up period.

Number of patients reporting complete cessation of daily PPI therapy at 36 months post TIF and 30 months post Crossover TIF combined into a single cohort.

Outcome measures

Outcome measures
Measure	Treatment Arm n=52 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With Complete Discontinuation of Daily PPI Therapy (Secondary Endpoint)	37 Participants	0 Participants

POST_HOC outcome

Timeframe: 36 months

Population: Control/Crossover patients have been added to the Treatment arm patients to make one combined cohort of patients. Control/Crossover patients are at 30 months post TIF.

Assessment of number of participants reporting healed esophagitis after TIF using EGD and LA grading system, LA grade A, B, C, D, with A meaning least severe esophagitis. No grade means normal. 30 months post TIF for Crossover patients.

Outcome measures

Outcome measures
Measure	Treatment Arm n=22 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With Healed Esophagitis (Secondary Endpoint)	19 Participants	0 Participants

POST_HOC outcome

Timeframe: 36 months

Population: All patients included in one cohort, entered in the treatment arm section

Satisfaction with current health condition OFF PPIs is reported as part of the GERD health-related quality of life questionnaire (GERD-HRQL), with 3 possible answers: satisfied, neutral or dissatisfied.

Outcome measures

Outcome measures
Measure	Treatment Arm n=43 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Patients Satisfied With Their Current Health Condition (Secondary Endpoint)	35 Participants	0 Participants

POST_HOC outcome

Timeframe: 60 months

Population: There were 44 patients available for follow up at 5 years post TIF. 43 were analyzed for regurgitation. Treatment and Control/Crossover patients were combined into one cohort, shown in Treatment arm. Control arm value is 0. Control/crossover patients are at 54 months post TIF.

Number of patients reporting elimination of troublesome regurgitation using the validated Reflux Disease Questionnaire (RDQ), a 12-item questionnaire to assess frequency and severity of heartburn (4 items measure frequency/severity of pain and burning behind breastbone), regurgitation (4 items measuring frequency/severity of acid taste in mouth and movement of material upward from stomach), and dyspeptic complaints (4 items measure frequency/severity of pain or burning in upper stomach). 9 response options range from 0 (not present) to 5 (daily) for frequency and 0 (not present) to 5 (severe) for severity. Each patient's score is calculated as the mean of item responses, with higher scores indicating more frequent and/or severe symptoms. Cohort of patients reported at this time period includes Treatment arm patients and Control/Crossover patients combined as 1 group. Control/Crossover patients included in cohort are at 54 months post TIF.

Outcome measures

Outcome measures
Measure	Treatment Arm n=43 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants With Elimination of Daily Troublesome Regurgitation (Primary Endpoint)	37 Participants	0 Participants

POST_HOC outcome

Timeframe: 60 months

Population: Control/crossover patients are included in overall number of patients analyzed and entered in Treatment arm section to make one cohort. Crossover patients are at 54 month post TIF follow up.

Number of patients with elimination of troublesome GERD symptoms using Reflux Symptom Index (RSI), a 9-item validated questionnaire to measure atypical GERD symptoms such as hoarseness, throat clearing, excess throat mucus, dysphagia, and cough. The scale for each individual item ranges from 0 (no problem) to 5 (severe problem), with a maximum total score of 45 and a normality threshold of ≤13. The lower the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Treatment Arm n=39 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Patients With Elimination of Troublesome Atypical GERD Symptoms (Primary Endpoint)	31 Participants	0 Participants

POST_HOC outcome

Timeframe: 60 months

Population: One cohort of patients entered as Overall number of Participants Analyzed, in Treatment arm section. Includes all available Control/crossover patients at 54 month post TIF follow up.

Number of participants with complete cessation of daily PPI use, self-reported by patient at 60 month follow-up. (54 months for Control/crossover patients). Note: all patients were on daily PPIs at screening (100%).

Outcome measures

Outcome measures
Measure	Treatment Arm n=44 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Patients Reporting Complete Cessation of Daily PPIs (Secondary Endpoint)	20 Participants	0 Participants

POST_HOC outcome

Timeframe: 60 months

Population: Overall Number of Participants Analyzed entered in Treatment arm includes all Control/crossover arm patients available for follow up. Control/crossover patients are at 54 month post-TIF follow up.

Satisfaction with current health condition OFF PPIs is reported as part of the GERD health-related quality of life questionnaire (GERD-HRQL), with 3 possible answers: satisfied, neutral or dissatisfied. 60 months post TIF, 54 months post Crossover.

Outcome measures

Outcome measures
Measure	Treatment Arm n=44 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants Satisfied With Their Current Health Condition (Secondary Endpoint)	31 Participants	0 Participants

POST_HOC outcome

Timeframe: 60 months

Population: All participants are included in the Overall Number of Participants Analyzed, under the Treatment arm section; reported as 1 cohort.

Reoperations completed post TIF by the end of 60 month (54 months post Crossover) follow up. These included 2 Laparoscopic Nissen fundoplications and 1 Dor fundoplication, completed without difficulty. This number includes the two reoperations reported and included in number of participants analyzed, at 36 month follow up.

Outcome measures

Outcome measures
Measure	Treatment Arm n=60 Participants Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Number of Participants Undergoing Reoperation Post-TIF (Secondary Endpoint)	3 Participants	0 Participants

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Arm n=41 participants at risk Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. EsophyX System with SerosaFuse fasteners: Transoral Incisionless Fundoplication (TIF)/Transoral Incisionless Esophago-Gastric Fundoplication	Control n=24 participants at risk Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial.
Gastrointestinal disorders Post operative TIF procedure	2.4% 1/41 • Number of events 1 • Adverse event data was collected over a period of 6 months	0.00% 0/24 • Adverse event data was collected over a period of 6 months
General disorders Post operative TIF procedure	2.4% 1/41 • Number of events 1 • Adverse event data was collected over a period of 6 months	0.00% 0/24 • Adverse event data was collected over a period of 6 months

Additional Information

Adrian Lobontiu

EndoGastric Solutions

Phone: 650-474-9259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place