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NCT07004439Possibly a fitNot yet recruiting

Study of a device to treat acid reflux

Gastroesophageal Reflux Disease

Part of Digestive system clinical trials.

This trial is testing a device called RefluxStop™ that is implanted during keyhole surgery to treat acid reflux (GERD). The study will check how safe and effective the device is for people with long-term GERD, and it aims to help reduce heartburn and other reflux symptoms.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
500 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must be 18 years or older.
  • You must have had GERD (acid reflux) symptoms, like heartburn, for at least 6 months.
  • You must have had a 24-hour pH or impedance test that confirmed acid reflux, while being off acid-reducing medication (PPIs) for at least 7 days before the test.
  • You must be healthy enough to undergo general anesthesia and laparoscopic surgery (keyhole surgery).
  • You cannot have a hiatal hernia larger than 8 cm, delayed stomach emptying, or a history of certain bariatric surgeries.
  • You cannot be pregnant or have a known allergy to silicone.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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