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Hernia Reduction Prior to Scheduled TIF Completion (HEURISTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
EndoGastric Solutions

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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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
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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
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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
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
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Information from the National Library of Medicine

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


Locations
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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
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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
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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

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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:
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Hernia
Pathological Conditions, Anatomical