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Tiny implant could stop heartburn without pills

NCT ID NCT04793035

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This early study tests a small, permanent device called the Omega-Cuff in 8 adults with GERD. Placed around the weak esophageal sphincter during keyhole surgery, it aims to block acid from backing up while allowing food to pass normally. Researchers will check safety, acid levels, symptoms, and quality of life over one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Omega-Cuff device (a permanent nitinol implant placed around the lower esophageal sphincter via laparoscopic surgery)
What this could lead to
If successful, this device could offer a long-term, non-drug option to control acid reflux without interfering with swallowing.
What could go wrong
This is a very early feasibility study with only 8 participants, so results may not apply to all GERD patients. The device is permanent and requires surgery, with unknown long-term risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6 people

The number who actually took part.

Started

Aug 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * • 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 is a suitable surgical candidate, i.e., is able to undergo general anesthesia and laparoscopic surgery. * Subject has documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months (regurgitation or heartburn that is defined as a burning epigastric or substernal pain that responds to acid neutralization or suppression). * Subject requires daily proton pump inhibitor or other anti-reflux drug therapy. * Total Distal Ambulatory Esophageal pH must meet the following criteria: pH\< 4 for ≥ 4.5% of the time Note: Subjects will have discontinued any GERD medications for at least 10 days prior to testing. * 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. * Subject has GERD symptoms in absence of PPI therapy (minimum 10 days). * 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. * Subject has been informed of the study procedures and the treatment and has signed an informed consent form. Exclusion Criteria: * • The procedure is an emergency procedure. * Subject is currently being treated with another investigational drug or investigational device. * Subject has a history of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal/gastric cancer. * Subject has undergone any previous endoscopic anti-reflux intervention for GERD. * Subject has suspected or confirmed esophageal or gastric cancer. * Subject has any size hiatal hernia \>3cm as determined by endoscopy. * Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or \<70% (propulsive) peristaltic sequences. * Subject has esophagitis Grade C or D (LA Classification). * Subject has a Body Mass Index (BMI)\>35. * Subject has symptoms of dysphagia more than once per week within the last 3 months. * Subject is diagnosed with Scleroderma or an esophageal motility disorder such as but not limited to Achalasia, Nutcracker Esophagus, or Diffuse Esophageal Spasm or Hypertensive LES. * Subject has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.). * Subject has esophageal or gastric varices. * Subject has a history of or known Barrett's esophagus. * Subject cannot understand trial requirements or is unable to comply with the follow-up schedule. * Subject is pregnant or nursing or plans to become pregnant during the course of the study. * Subject has a medical illness (e.g., congestive heart failure) that may cause the subject to be non-compliant with or unable to meet the protocol requirements or is associated with limited life expectancy (i.e., less than 3 years). * Subject is diagnosed with a psychiatric disorder (e.g., bipolar, schizophrenia, etc.); however, subjects who exhibit depression but are on appropriate medication(s) may be included. * Subject has suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials. * Subject has an electrical implant or metallic abdominal implants. * Subject is not a surgical candidate for open laparotomy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • HonorHealth

    Scottsdale, Arizona, 85258, United States

  • Keck Medical Center of University of Southern California

    Los Angeles, California, 90033, United States

  • University of Texas at Austin

    Austin, Texas, 78712, United States

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