Omega-Cuff Device for GERD

Recruiting at 2 trial locations

Overseen By Stephanie Doggett, PA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aplos Medical

Must be taking: Proton pump inhibitors

Disqualifiers: Gastroesophageal surgery, Hiatal hernia, Esophagitis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

8 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to stop taking GERD medications, like proton pump inhibitors, for at least 10 days before certain tests. It doesn't specify about other medications, so you may need to discuss this with the trial team.

What data supports the effectiveness of the Omega-Cuff Device treatment for GERD?

Research on similar treatments, like the magnetic sphincter augmentation device, shows that using magnetic force to strengthen the lower esophageal sphincter can significantly reduce symptoms of GERD. Studies have demonstrated that this approach is effective in reducing regurgitation and improving quality of life for patients. ^{1 2 3 4 5}

How is the Omega-Cuff Device treatment for GERD different from other treatments?

The Omega-Cuff Device is unique because it uses magnetic force to enhance the function of the lower esophageal sphincter (a muscle that prevents stomach acid from moving up into the esophagus), and it is implanted laparoscopically (a minimally invasive surgery). This approach is different from traditional drug treatments or surgical procedures like fundoplication, which involves wrapping the top of the stomach around the lower esophagus. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

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

If the subject is of child-bearing potential, she must have a negative pregnancy test within one week prior to implant and must agree to use effective means of birth control during the course of the study

Subject is willing and able to cooperate with follow-up examinations

Exclusion Criteria

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

Subject has a Body Mass Index (BMI)>35

I understand the trial requirements and can follow the schedule.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo laparoscopic surgical procedure to implant the Omega-Cuff device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up assessments at discharge, 2-4 weeks, 2, 3, 6, 9, and 12 months

12 months

Multiple visits (in-person)

Long-term Follow-up

Participants continue to be monitored for long-term safety and effectiveness of the Omega-Cuff device

Ongoing

Treatment Details

Interventions

• Omega-Cuff

Trial Overview 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.

Participant Groups

Group I: Enrolled patients Experimental Treatment 1 Intervention

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

Omega-Cuff is already approved in United States for the following indications:

Approved in United States as Omega-Cuff for:

• Gastroesophageal reflux disease (GERD)

Who Is Running the Clinical Trial?

Aplos Medical

Lead Sponsor

Trials

1

Recruited

8+

CT Resources, Inc

Lead Sponsor

Trials

1

Recruited

8+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a study of 30 patients with gastro-oesophageal reflux disease, a new magnetic device significantly improved symptoms, with the GORD-HRQL score dropping from 24.4 to 2.2 after 3 months (p < 0.001).

At one year, all patients had stopped using proton pump inhibitors, and 70% had a normal DeMeester score, indicating effective long-term management of their condition without losing the ability to belch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic oesophageal sphincter for the treatment of gastro-oesophageal reflux disease: results of a prospective clinical trial]. Nencioni, M., Asti, E., Saino, G., et al.[2009]

The magnetic device for augmenting lower esophageal sphincter function in GERD patients showed significant and sustained improvement in reflux control over 5 years, with GERD-related quality of life scores decreasing from a median of 27 to 4.

There were no device-related complications such as erosions or malfunctions, and the need for proton pump inhibitors dropped from 100% of patients at baseline to only 15.3% after 5 years, indicating both safety and efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Ganz, RA., Edmundowicz, SA., Taiganides, PA., et al.[2022]

Magnetic sphincter augmentation (MSA) effectively controlled regurgitation in 96% of patients with moderate to severe GERD who did not respond to proton-pump inhibitors (PPIs), demonstrating superior efficacy compared to PPIs, where only 19% of patients reported control.

MSA not only significantly reduced regurgitation but also improved overall quality of life for 81% of patients, with a notable decrease in dysphagia and bloating, and no serious adverse events reported, indicating a safe and effective long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial. Bell, R., Lipham, J., Louie, BE., et al.[2021]

Transoral incisionless fundoplication (TIF) using the EsophyX™ device effectively reduced the need for proton pump inhibitors (PPIs) in 75-80% of GERD patients over a follow-up period of up to 6 years, indicating its long-term efficacy.

Patients experienced significant reductions in GERD symptoms and reflux episodes after TIF, with factors like pre-procedure Hill's grade and absence of hiatal hernia predicting better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study. Testoni, PA., Testoni, S., Mazzoleni, G., et al.[2022]

The Magnetic Sphincter Augmentation (MSA) device was safely implanted in 38 out of 41 patients with no operative complications, allowing for a free diet post-surgery and a high discharge rate (97% within 48 hours).

After one year, patients showed significant improvement in GERD symptoms, with a reduction in GERD-HRQL scores from 26.0 to 1.0, and 89% of patients were off anti-reflux medications, indicating the device's efficacy in treating gastroesophageal reflux disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. Bonavina, L., Saino, GI., Bona, D., et al.[2022]

The magnetic lower esophageal sphincter augmentation device offers a new surgical option for managing gastroesophageal reflux disease (GERD), providing an alternative to traditional fundoplication.

The paper outlines a detailed technique for the laparoscopic removal of the device, highlighting the importance of having a clear protocol for surgeons in case device removal is required.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic lower esophageal sphincter augmentation device removal. Harnsberger, CR., Broderick, RC., Fuchs, HF., et al.[2021]

In a study involving 3283 patients who received the magnetic sphincter augmentation device (MSAD) for GERD, there were no reported deaths or life-threatening events, indicating a strong safety profile for this treatment.

The overall device removal rate was low at 2.7%, with the most common reasons being dysphagia and persistent reflux symptoms, suggesting that while some patients may experience issues, the majority tolerate the device well over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower Esophageal Sphincter Augmentation for Gastroesophageal Reflux Disease: The Safety of a Modern Implant. Smith, CD., Ganz, RA., Lipham, JC., et al.[2018]

The pepsin lateral flow device (LFD) demonstrated a sensitivity of 87% and specificity of 87% in detecting salivary pepsin, indicating it is a reliable noninvasive test for diagnosing gastroesophageal reflux disease (GERD).

The test showed a positive predictive value (PPV) of 81% and a negative predictive value (NPV) of 78% for patients with objective evidence of GERD, suggesting that a positive result could reduce the need for more invasive and costly diagnostic procedures like esophagogastroduodenoscopy (EGD) or pH monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid salivary pepsin test: blinded assessment of test performance in gastroesophageal reflux disease. Saritas Yuksel, E., Hong, SK., Strugala, V., et al.[2017]

References

1. Italy pubmed.ncbi.nlm.nih.gov

[Magnetic oesophageal sphincter for the treatment of gastro-oesophageal reflux disease: results of a prospective clinical trial]. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Magnetic lower esophageal sphincter augmentation device removal. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Lower Esophageal Sphincter Augmentation for Gastroesophageal Reflux Disease: The Safety of a Modern Implant. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Rapid salivary pepsin test: blinded assessment of test performance in gastroesophageal reflux disease. [2017]