What side effects are associated with this type of intervention?

Common treatments for GERD that increase pressure on the esophageal sphincter, such as fundoplication and the LINX device, can have side effects including difficulty swallowing (dysphagia), bloating, and gas. Pharmacological treatments like proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs) may cause headaches, diarrhea, constipation, and, in long-term use, potential nutrient deficiencies and increased risk of bone fractures. Each treatment option has its own risk profile, and patients should discuss these with their healthcare provider to determine the best approach for their condition.

What prior FDA approvals exist?

FDA-approved treatments for GERD primarily include pharmacologic therapies such as proton pump inhibitors (PPIs) like omeprazole, esomeprazole, and lansoprazole, which reduce stomach acid production. H2-receptor antagonists (H2RAs) like ranitidine and nizatidine are also used. For mechanical interventions similar to the Omega-Cuff, the FDA has approved devices like the LINX Reflux Management System, which consists of a ring of magnetic beads placed around the lower esophageal sphincter to augment its function and prevent acid reflux. These treatments aim to either reduce acid production or enhance the barrier function of the esophageal sphincter.

What other types of research exist?

Promising novel alternatives to the Omega-Cuff for GERD treatment include: 1) Magnetic Sphincter Augmentation Device, which uses magnetic beads to enhance lower esophageal sphincter function, and has shown efficacy in long-term studies. 2) Endoscopic procedures like Transoral Incisionless Fundoplication (TIF), which reconstructs the valve between the esophagus and stomach to prevent reflux. 3) LINX Reflux Management System, another magnetic device that augments the lower esophageal sphincter to prevent acid reflux. These alternatives offer different mechanisms to improve esophageal sphincter function and reduce GERD symptoms.

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Device

Omega-Cuff Device for GERD

Q: What is the mechanism of action of this treatment?

Common treatments for Gastroesophageal Reflux Disease (GERD) include pharmacological agents like proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs), which work by reducing stomach acid production. Non-pharmacological treatments, such as the Omega-Cuff, aim to increase the pressure on the lower esophageal sphincter (LES) to prevent acid reflux. This approach is particularly important for GERD patients as it directly targets the mechanical dysfunction of the LES, a primary cause of acid reflux, thereby providing a more permanent solution to minimize symptoms and improve quality of life.

N/A

Recruiting

Research Sponsored by Aplos Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must be at least 22 years of age and must be less than 75 years of age with a life expectancy > 3 years

Subject has a symptomatic improvement on proton-pump inhibitor (PPI) therapy demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10 on proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6-point improvement when comparing his/her on-PPI and off-PPI GERD-HRQL score

Must not have

Subject has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.)

Subject cannot understand trial requirements or is unable to comply with the follow-up schedule

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the Omega-Cuff, a device that helps prevent acid reflux by supporting the muscle at the bottom of the esophagus. It is for GERD patients who don't get relief from medications. The device increases pressure to stop acid from coming up but still lets food go down easily.

Who is the study for?

This trial is for adults aged 22-75 with chronic GERD symptoms, who respond to proton-pump inhibitors but still experience significant acid reflux (pH<4 over 4.5% of the time). Candidates must be able to undergo surgery and agree to birth control if applicable. Exclusions include previous gastroesophageal surgeries, large hiatal hernias, severe esophagitis, high BMI (>35), certain motility disorders, metal allergies, and those with implants that could interfere.

What is being tested?

The Omega-Cuff device is being tested in this study. It's a permanent implant placed laparoscopically at the esophageal sphincter to help prevent acid reflux without affecting swallowing. The study aims to assess its functionality and safety in up to 15 patients over a year.

What are the potential side effects?

Potential side effects may include discomfort or complications from surgery, reactions specific to the implant material such as irritation or allergic response (in case of undiagnosed metal allergy), and possible issues related to general anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 75 years old with an expected lifespan of more than 3 years.

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My acid reflux symptoms improve significantly with PPI medication.

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I take daily medication for acid reflux.

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I am fit for surgery and can undergo general anesthesia.

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My acid reflux test shows pH<4 for more than 4.5% of the time without GERD medication for 10 days.

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I have had symptoms like heartburn or acid reflux for more than 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known issue with my esophagus, like a stricture or abnormal shape.

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I understand the trial requirements and can follow the schedule.

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My procedure is classified as an emergency.

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My esophagus has weak muscle movements.

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I have a hiatal hernia larger than 3cm.

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I have severe esophagitis.

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I have been diagnosed with Scleroderma or a disorder affecting how my esophagus moves.

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I have been diagnosed with Barrett's esophagus.

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I have had surgery for acid reflux, stomach issues, or stomach cancer.

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I have varicose veins in my esophagus or stomach.

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I have had trouble swallowing more than once a week in the last 3 months.

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I have had a procedure to treat acid reflux.

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I have or might have cancer in my esophagus or stomach.

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I cannot undergo major abdominal surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Outcome 1

Outcome 2

Outcome 3

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Enrolled patientsExperimental Treatment1 Intervention

Single-arm study for enrolled GERD patients to be treated with an Omega-Cuff device

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Gastroesophageal Reflux Disease (GERD) include pharmacological agents like proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs), which work by reducing stomach acid production. Non-pharmacological treatments, such as the Omega-Cuff, aim to increase the pressure on the lower esophageal sphincter (LES) to prevent acid reflux. This approach is particularly important for GERD patients as it directly targets the mechanical dysfunction of the LES, a primary cause of acid reflux, thereby providing a more permanent solution to minimize symptoms and improve quality of life.