Hernia Reduction Prior to Scheduled TIF Completion (HEURISTIC)
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ClinicalTrials.gov Identifier: NCT03280121 |
Recruitment Status :
Terminated
(Slow enrollment and Covid-19)
First Posted : September 12, 2017
Results First Posted : January 7, 2021
Last Update Posted : February 10, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fundoplication | Device: EsophyX ZR transoral device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Prospective, investigator initiated, multicenter, non-randomized single arm, open label. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Hernia Reduction Prior to Scheduled TIF Completion- The HEURISTIC Study |
Actual Study Start Date : | October 5, 2018 |
Actual Primary Completion Date : | April 30, 2020 |
Actual Study Completion Date : | October 26, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: 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
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Device: EsophyX ZR transoral device
TIF |
- pH Study [ Time Frame: 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
- Number of Participants With a Change in Troublesome Symptoms From Baseline [ Time Frame: 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 [ Time Frame: 6 months ]from daily use to occasional use or none at all.

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Ages Eligible for Study: | 18 Years to 72 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-72 years
- 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
- 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
- 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
- Normal or near normal esophageal motility (by Upper GI/ esophagram or manometry as required)
- Pre-enrollment Hiatal Hernia (axial height and transverse dimension) from > 2 cm up to 4 cm inclusive.
- Patient willing to cooperate with post-operative dietary recommendations and assessment tests at the requisite follow-up visits
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280121
United States, Indiana | |
Elkhart General Hospital | |
Elkhart, Indiana, United States, 46514 | |
United States, Michigan | |
Aspirus Iron River Hospital | |
Iron River, Michigan, United States, 49935 | |
United States, Nevada | |
Northern Nevada Medical Center | |
Sparks, Nevada, United States, 89434 |
Principal Investigator: | Michael Murray, MD,FACS | Northern Nevada Medical Group |
Documents provided by EndoGastric Solutions:
Responsible Party: | EndoGastric Solutions |
ClinicalTrials.gov Identifier: | NCT03280121 |
Other Study ID Numbers: |
D031517 |
First Posted: | September 12, 2017 Key Record Dates |
Results First Posted: | January 7, 2021 |
Last Update Posted: | February 10, 2021 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
transoral incisionless |
Hernia Pathological Conditions, Anatomical |