EndoFLIP for Hiatal Hernia and Acid Reflux

Overseen By Nader M Hanna, MBBS, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Wiley Chung

Disqualifiers: Previous surgeries, Inability to consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Patients with reflux disease (heart burn), or a hiatal hernia, who do not get better with medication, may have surgery to help with their symptoms. Unfortunately, there is no agreed upon way to perform the surgery. The investigators are using a new surgical instrument called the EndoFLIP which allows surgeons to take measurements during the operation. The investigators will compare the measurements obtained during surgery with a quality of life score that we will calculate from a questionnaire.

Research Team

Wiley Chung, MD MHPE

Principal Investigator

Queen's University

Eligibility Criteria

This trial is for adults being evaluated for GERD (heartburn) or symptomatic hiatal hernia who are planning to have fundoplication surgery. It's not open to those who've had previous surgeries like hiatal hernia repair, fundoplication, esophagectomy, or gastrectomy, or can't consent.

Inclusion Criteria

I am an adult being evaluated for GERD or hiatal hernia and will have surgery to correct it.

Exclusion Criteria

I have had surgery on my esophagus or stomach.

I am unable to give consent by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Workup

Participants undergo esophagogastroduodenoscopy (EGD) and EndoFLIP readings are taken

2-4 weeks

1 visit (in-person)

Surgery

Participants undergo fundoplication surgery with intraoperative EndoFLIP measurements

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for post-operative symptoms and quality of life using GERD health-related quality of life score

4 months

2 visits (in-person)

Treatment Details

Interventions

• EndoFLIP

Trial Overview The study tests the EndoFLIP instrument during fundoplication surgery. Surgeons will use it to take measurements that could influence surgical technique and outcomes. The goal is to see if these measurements correlate with improved quality of life post-surgery.

Participant Groups

Group I: EndoFLIP Experimental Treatment 1 Intervention

Intraop EndoFLIP measurements

Who Is Running the Clinical Trial?

Dr. Wiley Chung

Lead Sponsor

Trials

2

Recruited

120+

Dr. Wiley Chung

Lead Sponsor

Trials

2

Recruited

120+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc