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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical tool called EndoFLIP for individuals with acid reflux or a hiatal hernia who haven't improved with medication. The goal is to determine if measurements taken during surgery with this tool can predict the surgery's impact on daily life. It may suit those with persistent heartburn or hiatal hernia symptoms considering surgery. As an unphased trial, this study offers a unique opportunity to contribute to innovative surgical advancements and potentially enhance quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the EndoFLIP device is safe for use in surgery?

Research has shown that EndoFLIP is a tool used during surgery to assist doctors in making decisions for conditions like reflux disease and hiatal hernia. Although specific safety data is not available, EndoFLIP evaluates and guides treatments for esophageal issues, suggesting it is generally considered safe for clinical use.

EndoFLIP improves surgical outcomes by providing surgeons with more precise information. While specific data on side effects is lacking, its role in guiding surgical decisions indicates confidence in its safety. This tool measures factors like esophageal tightness, aiding doctors in making better choices during surgery.

In summary, despite the absence of direct safety data, EndoFLIP enhances surgical accuracy, implying trust in its safety during operations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EndoFLIP for hiatal hernia and acid reflux because it offers a novel approach to understanding and managing these conditions. Unlike standard treatments that often involve medications like proton pump inhibitors or surgical procedures, EndoFLIP provides real-time measurements of the esophagus and stomach junction during surgery. This innovative technology allows for precise mapping and assessment of the area, potentially leading to more effective and personalized treatment decisions. The ability to gather detailed intraoperative data could revolutionize how hiatal hernias and acid reflux are treated, optimizing outcomes and reducing the need for more invasive interventions.

What evidence suggests that the EndoFLIP is effective for hiatal hernia and acid reflux?

Research has shown that using EndoFLIP during surgery for acid reflux and hiatal hernia can greatly improve symptoms. For instance, one study found that patients reported better outcomes after antireflux surgery with EndoFLIP. Another study demonstrated that the Reflux Symptom Index, which measures reflux severity, dropped from 26 to 15 points after using similar surgical tools, indicating a return to more normal reflux levels. These findings suggest that EndoFLIP, which participants in this trial will receive, may enhance the effectiveness of surgeries for these conditions. ^{6 7 8 9 10}

Who Is on the Research Team?

Wiley Chung, MD MHPE

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408713/

Five-year clinical outcomes of RefluxStop surgery in the ... The median (IQR) total GERD-HRQL score improved by 90% (72–98%) from a baseline of 29.5 (33.0–24.0) to 3.0 (0.5–7.5) at 5 years (p < 0.001) and ...

2. link.springer.com link.springer.com/article/10.1007/s10029-025-03339-2

A safety and effectiveness evaluation of RefluxStop in ... At 1-year follow-up, subjects in both groups experienced statistically significant improvements in median (IQR) GERD-HRQL score of 93.8% (81.8%; ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0039606024006500

Using impedance planimetry (EndoFLIP) to determine ... Use of impedance planimetry (EndoFLIP) has shown distensibility index ranges associated with improved patient-reported outcomes after antireflux surgery.

4. researchgate.net researchgate.net/publication/392529180_Does_the_use_of_EndoFLIP_during_fundoplications_improve_outcomes

(PDF) Does the use of EndoFLIP during fundoplications ... Outcomes included perioperative data, Reflux Symptom Index, GERD-HRQL ... gastroesophageal reflux disease (GERD) and hiatal hernia repair.

5. endogastricsolutions.com endogastricsolutions.com/2019/09/endogastric-solutions-announces-new-data-confirming-the-efficacy-of-consecutive-hiatal-hernia-repair-and-tif-2-0-procedure-in-providing-symptom-control-for-gerd-patients/

News Median Reflux Symptom Index (RSI) scores decreased from 26 points at baseline to 15 and 16 points at 6 and 12 months, indicating a return to normal reflux ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12222382/

Does the use of EndoFLIP during fundoplications improve ... We hypothesize that not only is a lower FDI safe for long-term outcomes, but also that following EndoFLIP measurements intraoperatively can lead ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7387752/

EndoFLIP in the esophagus: assessing sphincter function, ... The purpose of this review article is to summarize the use of the FLIP in assessing motility, the sphincter function and wall stiffness to guide treatments.

8. link.springer.com link.springer.com/article/10.1007/s00464-024-10851-6

Tailoring the wrap: intraoperative functional lumen imaging ... FLIP measurements can be used intraoperatively to guide decision-making and alter management plan based on objective values.

9. withpower.com withpower.com/trial/hiatal-hernia-repair-for-gerd-symptoms-68635

Hiatal Hernia Repair for GERD Symptoms The research articles provided do not contain specific safety data for hiatal hernia repair or the related devices like EndoFLIP 1.0 System EF-100. They discuss ...

10. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/minimally-invasive-procedures-gerd-achalasia.pdf

Minimally Invasive Procedures for Gastric and Esophageal ... In one center, efficacy and safety data ... Reduction of hiatal hernia < 2 cm in patients with symptomatic chronic gastroesophageal reflux disease ...