Hernia Reduction Prior to Scheduled TIF Completion (HEURISTIC)

Hernia Reduction Prior to Scheduled TIF Completion- The HEURISTIC Study

Hernia Reduction Prior to Scheduled TIF Completion using EsophyX ZR transoral device

Study Overview

• Status: Terminated
• Conditions: Fundoplication
• Intervention / Treatment: Device: 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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Elkhart General Hospital
  • Michigan
    • Iron River, Michigan, United States, 49935
      • Aspirus Iron River Hospital
  • Nevada
    • Sparks, Nevada, United States, 89434
      • Northern Nevada Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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	Device: EsophyX ZR transoral device; TIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hour monitoring period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
Number of Participants With a Change in PPI Consumption From Baseline to 6 Months	from daily use to occasional use or none at all.	6 months

Collaborators and Investigators

• Sponsor: EndoGastric Solutions
• Investigators: Principal Investigator: Michael Murray, MD,FACS, Northern Nevada Medical Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 5, 2018
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): October 26, 2020

Study Registration Dates

• First Submitted: September 9, 2017
• First Submitted That Met QC Criteria: September 9, 2017
• First Posted (ACTUAL): September 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: transoral incisionless
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: D031517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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