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Hernia Reduction Prior to Scheduled TIF Completion (HEURISTIC)

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ClinicalTrials.gov Identifier: NCT03280121
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
EndoGastric Solutions

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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




Primary Outcome Measures :
  1. pH study [ Time Frame: 48 hour monitoring period ]
    Normalization in esophageal acid exposure is defined by ≤ 5.3% of total time pH < 4 in


Secondary Outcome Measures :
  1. reduction of troublesome symptoms [ Time Frame: 1 week ]
    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. PPI consumption reduction [ Time Frame: 1 week ]
    from daily use to occasional use or none at all.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-65 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.


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


Contacts
Contact: Cynthia C Harris, B.S. 7753922970 cindy@clinregconsult.com
Contact: Michael Daniel, BS,MS,MBA 4154070223 MADANIEL@clinregconsult.com

Locations
United States, Indiana
Elkhart General Hospital Not yet recruiting
Elkhart, Indiana, United States, 46514
Contact: Mamoon Raza, MD    574-296-3200    mamoonraza@gmail.com   
Contact: Kate Stanley       kstanley@elkhartclinic.com   
United States, Michigan
Aspirus Iron River Hospital Recruiting
Iron River, Michigan, United States, 49935
Contact: Medhat Fanous, MD    906-265-9001    medhat.fanous@gmail.com   
Contact: jeff kaliebe, MT    7158472273      
United States, Nevada
Northern Nevada Medical Center Not yet recruiting
Sparks, Nevada, United States, 89434
Contact: Michael J Murray, MD    775-356-4888    mmur62@hotmail.com   
Contact: Linda McKnight    7754282633    linda.mcknight@uhsinc.com   
Sponsors and Collaborators
EndoGastric Solutions

Responsible Party: EndoGastric Solutions
ClinicalTrials.gov Identifier: NCT03280121     History of Changes
Other Study ID Numbers: D031517
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by EndoGastric Solutions:
transoral incisionless