Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE) (NAVIGATE)

May 11, 2026 updated by: Enterra Medical, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Jan Tack, MD/PhD
  • France
      • Colombes, France
        • Recruiting
        • Hôpital Louis-Mourier
        • Principal Investigator:
          • Heithem Soliman, MD
      • Lyon, France, 69003
        • Recruiting
        • Hôpital Edouard Herriot - CHU de Lyon
        • Principal Investigator:
          • François Mion, MD
      • Pessac, France
        • Recruiting
        • CHU de Bordeaux
        • Principal Investigator:
          • Frank Zerbib, MD
      • Rouen, France, 76031
        • Recruiting
        • CHU de ROUEN
        • Principal Investigator:
          • Guillaume Gourcerol
        • Sub-Investigator:
          • Charlotte Desprez
        • Sub-Investigator:
          • Chloé Melchior
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
        • Principal Investigator:
          • Hans Törnblom, MD, PhD
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital NHS Foundation Trust
        • Principal Investigator:
          • Bu'Hussain Hayee, PhD
      • London, United Kingdom, NW1 6DB
        • Recruiting
        • University College London Hospital
        • Principal Investigator:
          • Natalia Zarate-Lopez, PhD
      • Manchester, United Kingdom, M23 9LT
        • Recruiting
        • Manchester University NHS Foundation Trust
        • Principal Investigator:
          • Dipesh Vasant, PhD
      • Manchester, United Kingdom, M3 4BG
        • Recruiting
        • Functional Gut Clinic
        • Principal Investigator:
          • Paul Goldsmith, MD
  • United States
    • Arizona
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Medicine of USC
        • Principal Investigator:
          • Caitlin Houghton, MD
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Hospital
        • Principal Investigator:
          • Christy Dunst, MD
      • San Francisco, California, United States, 94109
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Sujka, MD
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health
        • Principal Investigator:
          • Herbert M Hedberg, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health
        • Principal Investigator:
          • Thomas Nowak, MD
        • Sub-Investigator:
          • John Wo, MD
        • Contact:
          • Maureen Schilling
          • Phone Number: 317-278-2064
          • Email: maschi@iu.edu
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Principal Investigator:
          • Abigail Stocker, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Carmelita Moppins, APRN
        • Sub-Investigator:
          • Lindsay McElmurray, PA-C
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • Hackensack Meridian
        • Principal Investigator:
          • Seth Kipnis, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Anthony Lembo, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple Digestive Disease Center
        • Principal Investigator:
          • Henry P Parkman, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Reena Chokshi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ON Group

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.
Device: Enterra Therapy System

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.
Experimental: OFF Group

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.
Device: Enterra Therapy System

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vomiting Absolute Frequency
Time Frame: 4 Months
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
4 Months
Change in Nausea Severity Score
Time Frame: 12 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score
12 Months
Change in Vomiting Absolute Frequency
Time Frame: 12 Months
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
12 Months
Change in Total Symptom Score
Time Frame: 4 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score
4 Months
Change in Total Symptom Score
Time Frame: 12 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score
12 Months
Change in Quality of Life Score
Time Frame: 12 Months
As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score
12 Months
Change in Quality of Life Score
Time Frame: 4 Months
As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score
4 Months
Change in Early Satiety Score
Time Frame: 4 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) early satiety score
4 Months
Change in Postprandial Fullness Score
Time Frame: 4 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) postprandial fullness score
4 Months
Change in Abdominal Pain Score
Time Frame: 4 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) abdominal pain score
4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enterra Medical, Inc.

Collaborators

Bright Research Partners

Investigators

  • Study Director: Jason Hamann, PhD, Enterra Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2025

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENT-CL-5000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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