NauseaNCT01582100
Reletex for Nausea in GERD Patients
A study testing Reletex in people with Nausea, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea
- What is being tested?
- Reletex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
About this study
Official title: 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.
- Conditions
- Nausea
- Being tested
- Reletex
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReletexDevice
Neuromodulation device worn on the wrist
| Study group | Role | What they receive |
|---|---|---|
| GERD subjects with nausea | Experimental | subjects with GERD and nausea will receive treatment with Reletex Receives: Device: Reletex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Nausea in Patients With GERD
number of events of nausea with or without vomiting in patients with GERD in 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: study was terminated by investigator due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Pandolfino, Northwestern University
- Investigators
- John E Pandolfino, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582100
- Sponsor's protocol ID
- 56024
- Status last verified
- Jul 2014
- First submitted
- 19 Apr 2012
- Last updated
- 13 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reletex ™ Band as an Adjunct to Standard Therapy in Patients With GERD, Nausea With or Without Vomiting- A Pilot Study
- ClinicalTrials.gov ID
- NCT01582100
- Acronym / sponsor ID
- 56024
- Conditions
- Nausea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study was terminated by investigator due to low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Posted 13 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GERD subjects with nausea | Experimental | Device: Reletexsubjects with GERD and nausea will receive treatment with Reletex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReletexNeuromodulation device worn on the wrist | Device | GERD subjects with nausea |
Primary outcome
Incidence of Nausea in Patients With GERD
Time frame: 4 weeks
number of events of nausea with or without vomiting in patients with GERD in 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E Pandolfino, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reletex in people with Nausea, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Nausea in Patients With GERD (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.