Fundoplication
Conditions
Keywords
transoral incisionless
Brief summary
Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device
Detailed description
Evaluation of the relative merits, safety and effectiveness of the EsophyX ZR transoral device in performing the standardized TIF 2.0 procedure preceded by laparoscopic Hiatal Hernia repair in PPI-prescribed patients with persistent troublesome symptoms per the Montreal consensus definition
Interventions
DEVICEEsophyX ZR transoral device
TIF
Sponsors
EndoGastric Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, investigator initiated, multicenter, non-randomized single arm, open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-72 years 2. Dependent upon daily PPIs for \> 6 months. Daily use is defined as a double dose, or full dose or half dose taken daily for more than 80% of the total number of days during the proceeding evaluation period 3. Troublesome symptoms, specifically heartburn or regurgitation, while on optimized dose of PPI's Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2 days a week and are mild to severe in severity 4. Abnormal ambulatory (Bravo) pH study after off PPI therapy for 7 days, i.e. \> 5.3% of the time with pH \< 4 in a 48-hour monitoring period 5. Normal or near normal esophageal motility (by Upper GI/ esophagram or manometry as required) 6. Pre-enrollment Hiatal Hernia (axial height and transverse dimension) from \> 2 cm up to 4 cm inclusive. 7. Patient willing to cooperate with post-operative dietary recommendations and assessment tests at the requisite follow-up visits 8. Signed informed consent
Exclusion criteria
1\. BMI \> 35 2. Hiatal hernia ≤ 2 and \> 4 cm 3. Esophagitis Los Angeles grade C or D 4. Esophageal ulcer 5. Esophageal stricture 6. Long-segment Barretts esophagus (Prague: C \> 1, M \> 3) 7. Esophageal motility disorder 8. Pregnancy or plans for pregnancy in the next 12 months (in females) 9. Immunosuppression 10. ASA \> 2 11. Portal hypertension and/or varices 12. 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 13. Active gastro-duodenal ulcer disease 14. Gastric outlet obstruction or stenosis 15. Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment 16. Coagulation disorders 17. Atypical symptoms including gas bloat and dysphagia. 18. Any other presenting condition that in the opinion of the investigator would not make participation in this study in the patient's best interest. Post Enrollment Exclusion - 1\. Inability to repair Hiatal hernia with at least 2cm of intra-abdominal esophagus length.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pH Study | 48 hour monitoring period | Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH \< 4 in |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Change in Troublesome Symptoms From Baseline | 6 months | Per Montreal Consensus definition, troublesome symptoms are mild symptoms occurring two (2) or more days per week, or moderate/severe symptoms occurring more than 1 day per week |
| Number of Participants With a Change in PPI Consumption From Baseline to 6 Months | 6 months | from daily use to occasional use or none at all. |
Countries
United States
Participant flow
Recruitment details
There were two sites that recruited patients. One was in Iron Mountain. Michigan and one in Sparks, Nevada. The procedures were done in hospitals. The recruitment was from August 18 2018 through February 2019. The study was closed by the sponsor due to slow enrollment.
Participants by arm
| Arm | Count |
|---|---|
| TIF Using EsophyX ZR Transoral Device Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device
EsophyX ZR transoral device: TIF | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | screen failure - 3 hernia too small and 1 pH too low | 4 |
Baseline characteristics
| Characteristic | TIF Using EsophyX ZR Transoral Device |
|---|---|
| Age, Continuous | 62 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 1 / 14 |
Outcome results
Primary
pH Study
Number of Participants with Normalization of Esophageal Acid Exposure. Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH \< 4 in
Time frame: 48 hour monitoring period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TIF Using EsophyX ZR Transoral Device-(SINGLE ARM) | pH Study | 6 Participants |
Secondary
Number of Participants With a Change in PPI Consumption From Baseline to 6 Months
from daily use to occasional use or none at all.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TIF Using EsophyX ZR Transoral Device-(SINGLE ARM) | Number of Participants With a Change in PPI Consumption From Baseline to 6 Months | 8 Participants |
Secondary
Number of Participants With a Change in Troublesome Symptoms From Baseline
Per Montreal Consensus definition, troublesome symptoms are mild symptoms occurring two (2) or more days per week, or moderate/severe symptoms occurring more than 1 day per week
Time frame: 6 months
Population: The relatively small number of patients that were willing to come back for follow-up and assessment of outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TIF Using EsophyX ZR Transoral Device-(SINGLE ARM) | Number of Participants With a Change in Troublesome Symptoms From Baseline | 3 Participants |