Hernia Reduction Prior to Scheduled TIF Completion (HEURISTIC)

• ClinicalTrials.gov Identifier: NCT03280121
• Recruitment Status: Terminated
• First Posted: September 12, 2017
• Results First Posted: January 7, 2021
• Last Update Posted: February 10, 2021
• Sponsor: EndoGastric Solutions
• Information provided by (Responsible Party): EndoGastric Solutions

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Fundoplication	Device: EsophyX ZR transoral device	Not Applicable

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 Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 72 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

EndoGastric Solutions

Investigators

• Principal Investigator: Michael Murray, MD,FACS; Northern Nevada Medical Group

  Study Documents (Full-Text)

Documents provided by EndoGastric Solutions:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] December 19, 2017

More Information

• Responsible Party: EndoGastric Solutions
• ClinicalTrials.gov Identifier: NCT03280121
• Other Study ID Numbers: D031517
• First Posted: September 12, 2017
• 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

Keywords provided by EndoGastric Solutions:

transoral incisionless

Additional relevant MeSH terms:

Hernia; Pathological Conditions, Anatomical