NauseaNAVIGATENCT06464926
Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)
A study testing Enterra Therapy System in people with Nausea and Vomiting, run by Enterra Medical, Inc. at 22 sites in 5 countries.
Trial summary
The purpose of this research study is to determine if the Enterra® Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea, with or without vomiting, that have normal gastric emptying. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Enterra Therapy System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 23 Jun 2025to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Willing and able to complete the informed consent process
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged ≥18 years at time of informed consent
- Chronic, drug-refractory nausea that: a) has been present for more than 6 months, and b) has been active within the last 3 months prior to consent
- Patient is able to complete ANMS GCSI-DD surveys on a compatible smart device with: a) a minimum of four (4) ANMS GCSI-DD entries per week for two consecutive weeks, and b) an average ANMS GCSI-DD score for nausea severity of ≥2.5 during the same two-week period
- Refractory or intolerant to two or more of the following antiemetic drug classes: antihistamines, phenothiazines, serotonin type 3 receptor antagonists, dopamine type 2 receptor antagonists, anticholinergics, neurokinin receptor antagonists
Show all 9Show fewer
- Medically stable, in the opinion of the investigator, during the month prior to consent, with no planned modifications to medical therapy during the course of the study
- Normal gastric emptying as assessed by a qualifying gastric emptying test performed within 2 years of consent if no prior pyloric transection therapy, or within 2 years of consent and after the most recent pyloric transection therapy
- Normal upper endoscopy within 1 year prior to consent (e.g., absence of obstructions, ulcers, or cancers in the esophagus, stomach, or duodenum) performed within 1 year of consent if no prior pyloric transection therapy, or within 1 year of consent and after the most recent pyloric transection therapy
Who cannot join
- Cognitive impairment or other characteristic that would limit a patient's ability to complete study requirements
- Pyloric transection therapy completed within 1 year of consent
- Documented gastrointestinal (GI) obstruction or pseudo-obstruction
- History of primary swallowing disorders
- History of primary psychogenic vomiting
- History of primary eating disorder
Show all 35Show fewer
- History of cyclic vomiting syndrome
- History of rumination syndrome
- History of scleroderma
- History of amyloidosis
- History of cannabis hyperemesis syndrome
- Active H. pylori infection
- Evidence of bezoar during most recent endoscopy
- Previous gastric surgery of any type other than a pyloric transection therapy (i.e., pyloroplasty, pyloromyotomy, POP, or G-POEM)
- Uncontrolled thyroid disorder, in the opinion of the investigator
- History of seizures disorders
- Hemoglobin A1c >8.0%
- Peritoneal dialysis or unstable hemodialysis
- Parenteral or enteral nutritional support
- Active pancreatitis
- History of organ transplant, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease
- Other GI tract diseases and disorders that the investigator believes may have caused the patient's drug-refractory nausea and/or vomiting
- Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of consent
- Opioid use
- Current cannabis/cannabinoid use that exceeds: 3 days of usage per week, or 2 occurrences during each day of use, or 3 grams of total usage per week
- Heavy alcohol use, defined as: for men, consuming five or more drinks on any day or 15 or more per week; for women, consuming four or more drinks on any day or 8 or more per week
- Injection of Botox into the pyloric sphincter within 6 months of consent
- Active major levels of anxiety/depression, as determined by the investigator
- History of other clinically significant disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact the validity of the study results
- Life expectancy <1 year
- Pregnant or breastfeeding at the time of consent or intend to become pregnant during the study
- Any underlying disease leading to follow-up by MRI outside of current MR conditional indications
- Glucagon-like peptide 1 (GLP-1) agonist drug use within 6 months of consent
- Participation in other investigational clinical studies
- Existing or prior gastric electrical stimulator implantation
Trial locations and contacts
22 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Hannah Bearinger, PhD contact
22 sites in 5 countries
United States12 sites, 12 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Anthony Lembo, MD
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Herbert M Hedberg, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Reena Chokshi, MD
- Recruiting
Indiana University Health
Indianapolis, Indiana, 46202
Maureen Schilling, 317-278-2064, maschi@iu.edu
Thomas Nowak, MD
- Recruiting
Keck Medicine of USC
Los Angeles, California, 90033
Caitlin Houghton, MD
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Amy Perdue, RN, 502-560-8413, amy.perdue@louisville.edu
Abigail Stocker, MD, abigail.stocker@louisville.edu
- Recruiting
Hackensack Meridian
Neptune City, New Jersey, 07753
Seth Kipnis, MD
- Recruiting
Hoag Hospital
Newport Beach, California, 92663
Christy Dunst, MD
- Recruiting
Temple Digestive Disease Center
Philadelphia, Pennsylvania, 19140
Alexis Bailey, 215-707-7340, alexis.bailey1@temple.edu
Henry P Parkman, MD
- Recruiting
Sutter Health
San Francisco, California, 94109
Stefanie Roberts, 415-600-1107, Stefanie.roberts@sutterhealth.org
Christie Linh, 415-600-5764, Christie.linh@sutterhealth.org
- Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Aubrey Smith, Smith.Aubrey@mayo.edu
Alexandria Ramirez, Ramirez.Alexandria@mayo.edu
- Recruiting
University of South Florida
Tampa, Florida, 33606
Ilexsius Fiorillo, 813-844-7650, ilexsius@usf.edu
Beth Montera, 813-844-7948, bmontera@usf.edu
France4 sites, 4 recruiting
- Recruiting
Hôpital Louis-Mourier
Colombes
Heithem Soliman, MD
- Recruiting
Hôpital Edouard Herriot - CHU de Lyon
Lyon, 69003
François Mion, MD
- Recruiting
CHU de Bordeaux
Pessac
Frank Zerbib, MD
- Recruiting
CHU de Rouen
Rouen, 76031
Guillaume Gourcerol
Charlotte Desprez
United Kingdom4 sites, 4 recruiting
- Recruiting
University College London Hospital
London, NW1 6DB
Natalia Zarate-Lopez, PhD
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Bu'Hussain Hayee, PhD
- Recruiting
Manchester University NHS Foundation Trust
Manchester, M23 9LT
Dipesh Vasant, PhD
- Recruiting
Functional Gut Clinic
Manchester, M3 4BG
Paul Goldsmith, MD
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
Hans Törnblom, MD, PhD
About this study
Official title: A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System
The purpose of this research study is to determine if the Enterra® Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea, with or without vomiting, that have normal gastric emptying.
Read the detailed description
Participants in this study will have an Enterra® Therapy System implanted and be assigned to a study group. Participants will answer daily questions about their nausea and vomiting symptoms and quality of life impacts with their smart device. Participants will answer quality of life questionnaires about their symptoms at study visits. Participants will be involved in this study for approximately twelve months after their study group is assigned.
- Being tested
- Enterra Therapy System
- Keywords
- Chronic, Nausea, Vomiting, Gastric Electrical Stimulation
- Medical subject headings
- Nausea, Vomiting, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterra Therapy SystemDevice
The Enterra Therapy System is a gastric electrical stimulator system consisting of an implantable pulse generator (Enterra II Model 37800 neurostimulator); two implantable unipolar leads (Enterra Model 4351-35 intramuscular); and device programmer (N'Vision Clinician Programmer Model 8840 with Model 8870 Application Card).
The programmable neurostimulator operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation through the implanted lead system. A clinician programmer is used to program the neurostimulator and adjust stimulation settings to programmable parameters and stimulation options.
| Study group | Role | What they receive |
|---|---|---|
| ON Group | Experimental | Participants assigned to the ON treatment group will begin with specified device programming values at the randomization visit. Device programming values may be adjusted at follow-up study visits during the blinding period.
At the conclusion of the 4-month visit, participants will have their devices programmed to individualized therapy as determined by the Investigator. Investigators may adjust programming values at additional follow-up study visits. Receives: Device: Enterra Therapy System |
| OFF Group | Experimental | Participants assigned to the OFF treatment group will begin with device programming values set to off at the randomization visit. These settings will continue until the 4-month visit.
At the conclusion of the 4-month visit, participants will receive specified device programming values. Device programming values may be adjusted at follow-up study visits. At the conclusion of the 8-month visit, participants will have their devices programmed to individualized therapy as determined by the Investigator. Receives: Device: Enterra Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nausea Severity Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score
Measured: 4 Months
Secondary outcomes (10)
Change in Vomiting Absolute Frequency
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency. Analysis only performed if ≥64 evaluable participants have a baseline weekly vomiting frequency of ≥5 per week
Measured: 4 Months
Change in Nausea Severity Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score
Measured: 12 Months
Change in Vomiting Absolute Frequency
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency. Analysis only performed if ≥64 evaluable participants have a baseline weekly vomiting frequency of ≥5 per week
Measured: 12 Months
Change in Total Symptom Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score
Measured: 4 Months
Change in Total Symptom Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score
Measured: 12 Months
Change in Quality of Life Score
As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score
Measured: 12 Months
Change in Quality of Life Score
As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score
Measured: 4 Months
Change in Early Satiety Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) early satiety score
Measured: 4 Months
Change in Postprandial Fullness Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) postprandial fullness score
Measured: 4 Months
Change in Abdominal Pain Score
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) abdominal pain score
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start23 Jun 2025
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assigned to ON or OFF group. ON group receives active therapy immediately after treatment assignment; OFF group receives active therapy after four months of treatment assignment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enterra Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Jason Hamann, PhD, Study director, Enterra Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464926
- Sponsor's protocol ID
- ENT-CL-5000
- Acronym
- NAVIGATE
- Status last verified
- May 2026
- First submitted
- 13 Jun 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System
- ClinicalTrials.gov ID
- NCT06464926
- Acronym / sponsor ID
- NAVIGATE / ENT-CL-5000
- Keywords
- Chronic, Nausea, Vomiting, Gastric Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Enterra Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine if the Enterra® Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea, with or without vomiting, that have normal gastric emptying.
Detailed description
Participants in this study will have an Enterra® Therapy System implanted and be assigned to a study group. Participants will answer daily questions about their nausea and vomiting symptoms and quality of life impacts with their smart device. Participants will answer quality of life questionnaires about their symptoms at study visits. Participants will be involved in this study for approximately twelve months after their study group is assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Assigned to ON or OFF group. ON group receives active therapy immediately after treatment assignment; OFF group receives active therapy after four months of treatment assignment.
| Arm | Type | Receives |
|---|---|---|
| ON Group | Experimental | Device: Enterra Therapy SystemParticipants assigned to the ON treatment group will begin with specified device programming values at the randomization visit. Device programming values may be adjusted at follow-up study visits during the blinding period. At the conclusion of the 4-month visit, participants will have their devices programmed to individualized therapy as determined by the Investigator. Investigators may adjust programming values at additional follow-up study visits. |
| OFF Group | Experimental | Device: Enterra Therapy SystemParticipants assigned to the OFF treatment group will begin with device programming values set to off at the randomization visit. These settings will continue until the 4-month visit. At the conclusion of the 4-month visit, participants will receive specified device programming values. Device programming values may be adjusted at follow-up study visits. At the conclusion of the 8-month visit, participants will have their devices programmed to individualized therapy as determined by the Investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to complete the informed consent process
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged ≥18 years at time of informed consent
- Chronic, drug-refractory nausea that: a) has been present for more than 6 months, and b) has been active within the last 3 months prior to consent
- Patient is able to complete ANMS GCSI-DD surveys on a compatible smart device with: a) a minimum of four (4) ANMS GCSI-DD entries per week for two consecutive weeks, and b) an average ANMS GCSI-DD score for nausea severity of ≥2.5 during the same two-week period
Key exclusion criteria (35 listed)
- Cognitive impairment or other characteristic that would limit a patient's ability to complete study requirements
- Pyloric transection therapy completed within 1 year of consent
- Documented gastrointestinal (GI) obstruction or pseudo-obstruction
- History of primary swallowing disorders
- History of primary psychogenic vomiting
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 |
|---|---|---|
| Enterra Therapy SystemThe Enterra Therapy System is a gastric electrical stimulator system consisting of an implantable pulse generator (Enterra II Model 37800 neurostimulator); two implantable unipolar leads (Enterra Model 4351-35 intramuscular); and device programmer (N'Vision Clinician Programmer Model 8840 with Model 8870 Application Card). The programmable neurostimulator operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation through the implanted lead system. A clinician programmer is used to program the neurostimulator and adjust stimulation settings to programmable parameters and stimulation options. | Device | OFF Group, ON Group |
Primary outcome
Change in Nausea Severity Score
Time frame: 4 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score
10 secondary outcomes
Change in Vomiting Absolute Frequency
Time frame: 4 Months
Change in Nausea Severity Score
Time frame: 12 Months
Change in Vomiting Absolute Frequency
Time frame: 12 Months
Change in Total Symptom Score
Time frame: 4 Months
Change in Total Symptom Score
Time frame: 12 Months
Change in Quality of Life Score
Time frame: 12 Months
Change in Quality of Life Score
Time frame: 4 Months
Change in Early Satiety Score
Time frame: 4 Months
Change in Postprandial Fullness Score
Time frame: 4 Months
Change in Abdominal Pain Score
Time frame: 4 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Nausea, Vomiting
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.
Hannah Bearinger, PhD contact
Jason Hamann, PhD study director
Enterra Medical, Inc.
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enterra Therapy System in people with Nausea and Vomiting, run by Enterra Medical, Inc. at 22 sites in 5 countries.
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 9 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, France, United Kingdom, Belgium, Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy McAllister (855-768-3772, clinicalresearch@enterramedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nausea Severity Score (time frame: 4 Months). 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 14 May 2026.