Reletex for Nausea in GERD Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Nausea
• Intervention / Treatment: Device: Reletex

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Faculty Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any patient over the age of 18 with clinically diagnosed GERD as evidenced by the GerdQ assessment tool and/or ambulatory pH/ pH- impedance monitoring with a component of nausea with or without vomiting.
• Continued symptoms despite a stable dose of FDA approved daily PPI therapy in addition to or without supportive anti-emetics. We will include patients with twice a day PPI dosing, as this is a standard treatment for PPI non-responders.
• Previous gastric emptying study performed as part of the standard care work-up of nausea and vomiting. Patients will be recruited regardless of the results and this information will only be used as a potential predictor for symptom response.

Exclusion Criteria:

• Currently participating in a concurrent clinical trial or completed another trial within past 8 weeks.
• Prior gastrointestinal surgery of the esophagus and stomach.
• Severe esophagitis (Los Angeles esophagitis Grade C and above), Barrett's metaplasia or eosinophilic esophagitis, achalasia or spastic motor disorder
• Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the physician-investigator can be included. Current drug or alcohol abuse or dependency.
• Current neurologic or cognitive illness or impairment which would make the patient an unsuitable candidate for hypnosis. This will be determined by the investigators before randomization using the Mini Mental Status Exam in patients with suspected impairment.
• Severe mental illness, e.g., uncontrolled major depression with suicidal ideation, active psychosis, diagnosis of schizophrenia-spectrum disorder.
• Those with nickel, gold, or other metal allergies.
• Those with other neuromodulators or implanted electrical devices such as cardiac pacemakers, AICD's, neurostimulators or transcutaneous electrical nerve stimulation devices (TENS units).
• Females who are or might become pregnant during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GERD subjects with nausea; subjects with GERD and nausea will receive treatment with Reletex	Device: Reletex; Neuromodulation device worn on the wrist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Nausea in Patients With GERD	number of events of nausea with or without vomiting in patients with GERD in 4 weeks	4 weeks

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: April 19, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (ESTIMATE): April 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea
• Other Study ID Numbers: 56024