Hernia Reduction Prior to Scheduled TIF Completion

NCT03280121 | Terminated Results FDA Device

• 1 other identifier: D031517
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Fundoplication

Keywords

transoral incisionless

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With a Change in Troublesome Symptoms From Baseline

  6 months

• Number of Participants With a Change in PPI Consumption From Baseline to 6 Months

  6 months

Study Arms (1)

TIF using EsophyX ZR transoral device

EXPERIMENTAL

Transoral incisionless fundoplication which is a minimally invasive treatment for gastroesophageal reflux disease (GERD) using EsophyX ZR transoral device

Device: EsophyX ZR transoral device

Interventions

EsophyX ZR transoral device DEVICE

TIF

TIF using EsophyX ZR transoral device

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-72 years
• 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
• 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
• 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
• Normal or near normal esophageal motility (by Upper GI/ esophagram or manometry as required)
• Pre-enrollment Hiatal Hernia (axial height and transverse dimension) from \> 2 cm up to 4 cm inclusive.
• Patient willing to cooperate with post-operative dietary recommendations and assessment tests at the requisite follow-up visits

You may not qualify if:

• \. 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.
• \. Inability to repair Hiatal hernia with at least 2cm of intra-abdominal esophagus length.

Sponsors & Collaborators

• EndoGastric Solutions: lead

Study Sites (3)

Elkhart General Hospital

Elkhart, Indiana, 46514, United States

Location

Aspirus Iron River Hospital

Iron River, Michigan, 49935, United States

Location

Northern Nevada Medical Center

Sparks, Nevada, 89434, United States

Location

Results Point of Contact

• Title: Cynthia Harris, Director of Clinical Trials
• Organization: Daniel and Daniel Consulting, LLC

cindy@clinregconsult.com

775-392-2975

Study Officials

• Michael Murray, MD,FACS

  Northern Nevada Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, investigator initiated, multicenter, non-randomized single arm, open label.

Study Record Dates

• First Submitted: September 9, 2017
• First Posted: September 12, 2017
• Study Start: October 5, 2018
• Primary Completion: April 30, 2020
• Study Completion: October 26, 2020
• Last Updated: February 10, 2021
• Results First Posted: January 7, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)