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

Recruiting in Palo Alto (17 mi)

Overseen byChristopher C. Thompson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christopher C. Thompson, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

See 1 more

Treatment Details

Interventions

Transoral Incisionless Fundoplication (TIF) (Procedure)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: LPR PatientsExperimental Treatment1 Intervention

Adults with a confirmed diagnosis of LPR with HEMII-pH (≥2 LPR events in 24 hr period), Esophageal manometry and Laryngoscopy undergoing endoscopic transoral incisionless fundoplication (TIF).