RECRUITING

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

Conditions

Nausea Vomiting Chronic Gastric Electrical Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients with Normal Gastric Emptying Using the Enterra® Therapy System

Quick Facts

Study Start:2024-12

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06464926

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 6 months prior to consent * Normal upper endoscopy within 1 year prior to consent (e.g., absence of obstructions, ulcers, or cancers in the esophagus, stomach, or duodenum)	* Cognitive impairment or other characteristic that would limit a patient's ability to complete study requirements * Evidence of a delayed gastric emptying test result within 2 years 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 * 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 * History of organ transplant, chronic pancreatitis, 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 in 12 months prior to consent * Participation in other investigational clinical studies * Existing or prior gastric electrical stimulator implantation

Inclusion Criteria

Exclusion 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 6 months prior to consent
* Normal upper endoscopy within 1 year prior to consent (e.g., absence of obstructions, ulcers, or cancers in the esophagus, stomach, or duodenum)

* Cognitive impairment or other characteristic that would limit a patient's ability to complete study requirements
* Evidence of a delayed gastric emptying test result within 2 years 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
* 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
* History of organ transplant, chronic pancreatitis, 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 in 12 months prior to consent
* Participation in other investigational clinical studies
* Existing or prior gastric electrical stimulator implantation

Contacts and Locations

Study Contact

Timothy McAllister

CONTACT

855-768-3772

clinicalresearch@enterramedical.com

Hannah Bearinger, PhD

CONTACT

hannah.bearinger@brightresearch.com

Principal Investigator

Jason Hamann, PhD

STUDY_DIRECTOR

Enterra Medical, Inc.

Study Locations (Sites)

Indiana University Health

Indianapolis, Indiana, 46202

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Collaborators and Investigators

Sponsor: Enterra Medical, Inc.

Jason Hamann, PhD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-12

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-12

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Chronic
Nausea
Vomiting
Gastric Electrical Stimulation

Additional Relevant MeSH Terms

Nausea
Vomiting