Clinical Trial: Reletex for Nausea in GERD Patients

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Reletex ™ Band as an Adjunct to Standard Therapy in Patients With GERD, Nausea With or Without Vomiting- A Pilot Study

Brief Summary: Gastroesophageal reflux disease (GERD) is a highly prevalent condition that is frequently encountered in the health care setting. It affects roughly 40% of Americans monthly and 10% weekly. Of those with GERD, there exists a cohort that experience nausea with or without vomiting that is unresponsive to PPI's and anti-emetics. For these patients, treatment options are limited and these symptoms may substantially alter their quality of life. New and novel therapies emerging include neuromodulation devices that may affect the central pathways leading to these symptoms. Of these, the Reletex band has been tested and proven efficacious in the treatment of nausea and vomiting associated with pregnancy, chemotherapy, and surgery, in addition to standard anti-nausea medications. The investigators propose that through a similar mechanism, this device as an adjunct to PPI's and anti-emetics will reduce GERD-associated the nausea with or without vomiting, and by so doing, improve the quality of lives in this patient population.

Detailed Summary:
Sponsor: Northwestern University

Current Primary Outcome: Incidence of Nausea in Patients With GERD [ Time Frame: 4 weeks ]

Original Primary Outcome: incidence and severity of nausea with or without vomiting in patients with GERD [ Time Frame: 4 weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Northwestern University

Dates:
Date Received: April 19, 2012
Date Started: March 2012
Date Completion:
Last Updated: November 5, 2014
Last Verified: July 2014