Trial Outcomes & Findings for Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study (NCT NCT01327963)
NCT ID: NCT01327963
Last Updated: 2020-12-03
Results Overview
Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of \<18) and Reflux Symptom Index (RSI measures atypical laryngopharyngeal (LPR) symptoms, scale 0-5 for each of 9 questions with maximum of 45 with a normality threshold of \< or = 13) questionnaires) at the follow-up.
TERMINATED
NA
110 participants
median 7 months (range 5-17 months)
2020-12-03
Participant Flow
124 patients were eligible to participate in the study, but 110 signed consent and started the study. Of the 14 that didn't start, 13 could not be reached at start of study and one patient did not receive the TIF procedure due to intraoperative hematoma.
Participant milestones
| Measure |
Transoral Incisionless Fundoplication
Intervention: Transoral Incisionless Fundoplication 2.0 technique iteration (TIF 2.0).
With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro-esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the Gastroesophageal Junction (GEJ) below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.
Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized transoral incisionless fundoplication 2.0 technique iteration (TIF2.0) protocol.
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
110
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
70 of 110 participants had a 2 or 3cm hiatal hernia at baseline
Baseline characteristics by cohort
| Measure |
Transoral Incisionless Fundoplication
n=110 Participants
Intervention: Transoral Incisionless Fundoplication: TIF 2.0 technique iteration.
With patient in general anesthesia. The EsophyX device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.
Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) prolene fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized TIF2.0 protocol.
|
|---|---|
|
Age, Continuous
|
64 years
n=110 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=110 Participants
|
|
Region of Enrollment
United States
|
110 participants
n=110 Participants
|
|
Body Mass Index (BMI) > or equal to 35
|
18 Participants
n=110 Participants
|
|
Gastroesophageal Reflux disease (GERD) symptom duration (years)
1-2 years
|
13 Participants
n=110 Participants
|
|
Gastroesophageal Reflux disease (GERD) symptom duration (years)
2-5 years
|
14 Participants
n=110 Participants
|
|
Gastroesophageal Reflux disease (GERD) symptom duration (years)
> or equal to 5 years
|
83 Participants
n=110 Participants
|
|
Proton Pump Inhibitor (PPI) therapy duration (years)
1-2 years
|
16 Participants
n=110 Participants
|
|
Proton Pump Inhibitor (PPI) therapy duration (years)
2-5 years
|
13 Participants
n=110 Participants
|
|
Proton Pump Inhibitor (PPI) therapy duration (years)
> or equal to 5 years
|
81 Participants
n=110 Participants
|
|
Hiatal hernia size
2cm hiatal hernia (sliding)
|
51 Participants
n=70 Participants • 70 of 110 participants had a 2 or 3cm hiatal hernia at baseline
|
|
Hiatal hernia size
3cm hiatal hernia (sliding)
|
19 Participants
n=70 Participants • 70 of 110 participants had a 2 or 3cm hiatal hernia at baseline
|
|
Esophagitis using Los Angeles (LA) grading
LA grade A
|
42 Participants
n=64 Participants • 64 of 110 participants had esophagitis at baseline
|
|
Esophagitis using Los Angeles (LA) grading
LA grade B
|
20 Participants
n=64 Participants • 64 of 110 participants had esophagitis at baseline
|
|
Esophagitis using Los Angeles (LA) grading
LA grade C
|
2 Participants
n=64 Participants • 64 of 110 participants had esophagitis at baseline
|
PRIMARY outcome
Timeframe: median 7 months (range 5-17 months)Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of \<18) and Reflux Symptom Index (RSI measures atypical laryngopharyngeal (LPR) symptoms, scale 0-5 for each of 9 questions with maximum of 45 with a normality threshold of \< or = 13) questionnaires) at the follow-up.
Outcome measures
| Measure |
Transoral Incisionless Fundoplication
n=110 Participants
Intervention: Transoral Incisionless Fundoplication: TIF 2.0 technique iteration.
With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.
Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless fundoplication 2.0 technique iteration (TIF2.0) protocol.
|
|---|---|
|
Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
Participants with normal GERD-HRQL scores
|
88 Participants
|
|
Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
Participants with controlled reflux symptoms measured by GERSS questionnaire
|
87 Participants
|
|
Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
Patients scoring in the normality threshold on RSI questionnaire
|
83 Participants
|
SECONDARY outcome
Timeframe: median 7 months (range 5-17 months)Population: There were no serious adverse events or UADE during the study.
The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication.
Outcome measures
| Measure |
Transoral Incisionless Fundoplication
n=110 Participants
Intervention: Transoral Incisionless Fundoplication: TIF 2.0 technique iteration.
With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.
Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless fundoplication 2.0 technique iteration (TIF2.0) protocol.
|
|---|---|
|
Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)
|
0 Participants
|
SECONDARY outcome
Timeframe: median 7 months (range 5-17 months)Patients reporting complete discontinuation of daily PPI use will be considered clinically significant.
Outcome measures
| Measure |
Transoral Incisionless Fundoplication
n=110 Participants
Intervention: Transoral Incisionless Fundoplication: TIF 2.0 technique iteration.
With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.
Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless fundoplication 2.0 technique iteration (TIF2.0) protocol.
|
|---|---|
|
Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use
|
102 Participants
|
SECONDARY outcome
Timeframe: median 7 months (range 5-17 months)Population: Of 53 patients examined at follow up for esophagitis or hiatal hernia status, 30 had reported esophagitis at baseline. Please note: there was 1 new case of esophagitis reported at follow-up, that had not been present at baseline.
One LA grade reduction will be considered clinically significant. LA grades are A, B, C, D, with A being the least severe esophagitis. No grade assigned is considered "normal", i.e. no esophagitis reported.
Outcome measures
| Measure |
Transoral Incisionless Fundoplication
n=30 Participants
Intervention: Transoral Incisionless Fundoplication: TIF 2.0 technique iteration.
With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.
Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless fundoplication 2.0 technique iteration (TIF2.0) protocol.
|
|---|---|
|
Number of Participants With Healing of Reflux Esophagitis
|
25 Participants
|
SECONDARY outcome
Timeframe: median 7 months (range 5-17 months)Population: 53 patients were assessed for esophagitis and presence of hiatal hernia at follow-up. Hiatal hernia was present at baseline and reduced during TIF procedure in 34 of the patients examined at follow-up. Hiatal hernia in 33 of 34 remained reduced at follow-up. Please note: there was one new case of hiatal hernia reported that had not been present at baseline.
Measurement obtained by study investigator, under endoscopic visualization using cm markings on the endoscope. Outcome measure assesses if hiatal hernia that was present at baseline and reduced (size reduction to \< 1 cm is considered clinically significant) during TIF procedure, has remained reduced at the post-TIF follow up exam.
Outcome measures
| Measure |
Transoral Incisionless Fundoplication
n=34 Participants
Intervention: Transoral Incisionless Fundoplication: TIF 2.0 technique iteration.
With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro -esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GEJ below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.
Transoral Incisionless Fundoplication: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless fundoplication 2.0 technique iteration (TIF2.0) protocol.
|
|---|---|
|
Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up
|
33 Participants
|
SECONDARY outcome
Timeframe: median 7 months (range 5-17 months)Population: Note: neither 48-hour Bravo pH nor 24-hour impedance/pH testing was completed. pH testing was unavailable at the study sites. Study protocol noted that testing would be completed "if available". In the absence of these testing tools, sites relied on detailed history, physical signs, symptom evaluation, barium swallow, and repeated esophagogastroduodenoscopy (EGD) with biopsy to make diagnosis. This continues to be the most commonly used method of GERD diagnosis among community physicians.
Esophageal acid exposure will be measured objectively by 48-hour Bravo Potential of Hydrogen (pH) or 24-hour impedance/pH testing at the follow-up (where pH testing is available). Normalization of esophageal acid exposure will be defined by total time pH\< 4 for ≤ 6% of 24-hour or for ≤ 5.3% of 48-hour monitoring period. The number of reflux episodes of ≤ 44 per each 24-hour period will be considered normal.
Outcome measures
Outcome data not reported
Adverse Events
Transoral Incisionless Fundoplication
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Adrian Lobontiu, Chief Medical Officer
EndoGastric Solutions
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place