WithdrawnNot Applicable

Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients

Stopped: Sponsor decided not to fund the study.

United States0Started 2024-03-30

Plain-language summary

In this research study the investigators want to learn more about the effectiveness of an endoscopic procedure (an endoscope is a lighted tube that is placed down the participants esophagus, through the participants mouth) which uses a device that allows the doctor to repair or recreate the body's natural barrier to reflux. It uses preloaded forceps (tweezers) and fasteners and requires no incision to tighten the connection between the participants esophagus and stomach. This procedure is performed to aid in the treatment of symptoms of Gastroesophageal Reflux disease (GERD) in patients with diagnosed Laryngopharyngeal reflux (LPR). LPR is a condition resulting from backflow of stomach contents into the laryngopharynx (connection point in the participants throat through which food, water, and air pass) resulting in symptoms that can be referred to larynx/hypopharynx. The device the investigators will use to perform the transoral incisionless fundoplication procedure (TIF) is called the EsophyX device. The participants have been asked to participate because they have been diagnosed with LPR and have either failed medical therapy (taking prescription proton pump inhibitors (PPI) to reduce stomach acid production or do not want to be on long-term medical treatment.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any adult with a confirmed diagnosis of LPR with HEMII-pH (≥2 LPR events in 24 hr period), Esophageal manometry and Laryngoscopy. * Having daily bothersome symptoms of LPR. * Willing and able to cognitively sign a consent form for Surgical treatment of LPR with the TIF. * Willing and available for follow up visit and repeat testing (HEMII-pH, Esophageal manometry and laryngoscopy) at 3 months post procedure. Exclusion Criteria: * Unable or unwilling to provide informed consent * Unable or unwilling to comply with study procedures * Body Mass Index \>35. * Hiatal hernia\>2cm in axial height and \>2cm in greatest transverse dimension. * Esophagitis grade C and D * Barrett's esophagus\>2cm * Esophageal ulcer * Fixed esophageal stricture or narrowing * Portal hypertension and/or varices * Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis * Gastroparesis * Coagulation disorders * History of any of the following: resective gastric or esophageal surgery, anti-reflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis * Pregnancy or plans of pregnancy in the next 12 months * Enrollment in another device or drug study that may confound the results. * Acute or chronic illness or history of illness which in the opinion of the investigator could pose a t…

What they're measuring

LPR Symptoms

Timeframe: Baseline and 3 months post-procedure

LPR Events

Timeframe: Baseline and 3 months post-procedure

Trial details

NCT IDNCT05579587

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-11-30