Reletex for Nausea in GERD Patients

Age Range:18 - Any
Start Date:March 2012
End Date:March 2015
Contact:Christine E Nelson

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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.

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

- 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.
We found this trial at
Chicago, Illinois 60611
Chicago, IL
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