Clinical trial NCT03280121: Hernia Reduction Prior to Scheduled TIF Completion
Official title: Hernia Reduction Prior to Scheduled TIF Completion- The HEURISTIC Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fundoplication
Keywords: transoral incisionless
Lead sponsor: EndoGastric Solutions
Sponsor class: INDUSTRY
First posted: 2017-09-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, investigator initiated, multicenter, non-randomized single arm, open label.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: pH Study
timeFrame: 48 hour monitoring period
Secondary outcomes:
measure: Number of Participants With a Change in Troublesome Symptoms From Baseline
timeFrame: 6 months
measure: Number of Participants With a Change in PPI Consumption From Baseline to 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Elkhart
country: United States
facility: Elkhart General Hospital
state: Indiana
city: Iron River
country: United States
facility: Aspirus Iron River Hospital
state: Michigan
city: Sparks
country: United States
facility: Northern Nevada Medical Center
state: Nevada
Study officials:
affiliation: Northern Nevada Medical Group
name: Michael Murray, MD,FACS
role: PRINCIPAL_INVESTIGATOR
References: