Omega-Cuff Device for GERD

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Omega-Cuff for people with gastroesophageal reflux disease (GERD), which causes acid to flow back into the esophagus and leads to discomfort like heartburn. The Omega-Cuff aims to prevent acid reflux by supporting the muscle that keeps stomach acid down, without affecting normal swallowing. The study will evaluate the device's effectiveness and safety for patients. It suits those who have experienced GERD symptoms for more than six months and require daily medication to manage their condition. As an unphased trial, this study allows patients to contribute to innovative research that could enhance GERD treatment options.

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 prior data suggests that the Omega-Cuff device is safe for GERD patients?

Research has shown that the Omega-Cuff device is generally well-tolerated by patients. In earlier studies, after a year of use, most patients experienced significant improvement in their acid reflux symptoms. Their GERD-HRQL scores, which measure the impact of acid reflux on daily life, dropped from 26.0 to 1.0, indicating a substantial reduction in symptoms. Additionally, 89% of these patients stopped taking their usual acid reflux medications.

The device, made from nitinol, is placed on the muscle above the stomach through a minor surgical procedure. Animal studies demonstrated that this device safely increased pressure on the muscle, preventing acid reflux while allowing normal swallowing, so patients could eat without issues.

Importantly, the Omega-Cuff is permanent but can be safely removed if necessary. It does not interfere with MRI scans, which are common medical imaging tests. These factors suggest the device is safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard GERD treatments that often involve medications like proton pump inhibitors (PPIs) to reduce stomach acid, the Omega-Cuff device offers a completely different approach by mechanically addressing the issue. This innovative device is designed to prevent acid reflux by applying gentle pressure to the lower esophageal sphincter, enhancing its ability to keep stomach contents from flowing back into the esophagus. Researchers are excited about the Omega-Cuff because it could provide a non-pharmaceutical option for GERD patients, potentially leading to fewer side effects and more sustainable long-term relief.

What evidence suggests that the Omega-Cuff device is effective for GERD?

Research has shown that the Omega-Cuff device might help treat GERD, also known as acid reflux, by increasing pressure on the muscle that prevents stomach acid from entering the esophagus. In a previous study, patients using the Omega-Cuff experienced a significant reduction in their GERD symptoms. Their scores on a test measuring the impact of GERD on quality of life dropped from 26.0 to 1.0. Impressively, 89% of patients no longer needed medication for GERD after using the device. Animal studies also found that the Omega-Cuff increased protection against acid reflux without making swallowing difficult. These findings suggest that the Omega-Cuff can effectively control GERD while allowing normal eating and drinking. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04793035

NCT04793035 | Omega Cuff for GERD Feasibility Study This clinical feasibility study is to evaluate the performance of the Omega-Cuff in the treatment of acid reflux for up to 15 patients with a 1-year ...

2. withpower.com withpower.com/trial/phase-gastroesophageal-reflux-8-2021-1d394

Omega-Cuff Device for GERD · Info for Participants 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 ...

3. medicalalley.org medicalalley.org/omega-pf-device-achieves-major-milestone-with-first-human-implant-at-dell-medical-center-of-university-of-texas-at-austin/

Omega PF™ Device Achieves Major Milestone with First ... Although esophageal restriction proves effective in stopping reflux, it unfortunately leads to dysphagia, as it equally restricts swallowing. ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4848240/

Transoral incisionless fundoplication for gastro-esophageal ... Outcomes are reported in detail, and a revision of the literature was performed to assess the efficacy of TIF in patients with GERD. Manuscripts were identified ...

5. cbs42.com cbs42.com/business/press-releases/cision/20231103CG57504/aplos-medical-achieves-a-major-milestone-in-gerd-treatment-with-omega-pf

Aplos Medical Achieves a Major Milestone in GERD ... The Omega PF™ device heralds a paradigm shift in GERD treatment. Being the first of its kind, the device seamlessly combines a dual-modality ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10789235/

Longer-term outcomes of gastroesophageal reflux disease ... GERD-HRQL and RSI scores are reduced postoperatively even in patients with severe reflux. Patients were able to stop or reduce their use of ...

7. aplosmed.com aplosmed.com/omegacuff/

Omega PF - Simplifying GERD Treatment How It Works. A laparoscopic surgery means no new skills are needed for surgeons, and quick relief for patients with acid reflux.

8. nsmedicaldevices.com nsmedicaldevices.com/company-news/aplos-medical-reports-first-implantation-of-omega-pf-in-gerd-treatment/

Aplos Medical reports first implantation of Omega PF in ... Aplos Medical has reported the first successful implantation of its Omega PF device for gastroesophageal reflux disease (GERD) treatment.