Using Enterra Therapy to Treat Chronic Nausea and Vomiting

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

This study is testing whether the Enterra Therapy System can help people with chronic nausea and vomiting feel better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Enterra Medical, Inc. (Industry-sponsored)
• Locations: 20 sites (Scottsdale, Arizona and 19 other locations)
• Trial ID: NCT06464926 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the effectiveness of the Enterra® Therapy System in reducing symptoms of chronic nausea and vomiting in patients who have normal gastric emptying. Participants will have the device implanted and will report their symptoms and quality of life through daily questionnaires on a smart device. The study will last approximately twelve months, during which participants will be monitored for changes in their condition and overall well-being. The goal is to determine if this therapy can significantly improve patients' quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic, drug-refractory nausea that has persisted for more than six months.

Not a fit: Patients who do not have chronic nausea or who have not responded to multiple antiemetic drug classes may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide significant relief from chronic nausea and vomiting, improving patients' quality of life.

How similar studies have performed: Other studies using gastric electrical stimulation have shown promise, suggesting potential success for this approach.

Eligibility criteria

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

Where this trial is running

Scottsdale, Arizona and 19 other locations

• Mayo Clinic Arizona — Scottsdale, Arizona, United States (Recruiting)
• Hoag Hospital — Newport Beach, California, United States (Recruiting)
• Sutter Health — San Francisco, California, United States (Recruiting)
• University of South Florida — Tampa, Florida, United States (Recruiting)
• Endeavor Health — Evanston, Illinois, United States (Recruiting)
• Indiana University Health — Indianapolis, Indiana, United States (Recruiting)
• University of Louisville — Louisville, Kentucky, United States (Recruiting)
• Hackensack Meridian — Neptune City, New Jersey, United States (Recruiting)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
• Temple Digestive Disease Center — Philadelphia, Pennsylvania, United States (Recruiting)
• Baylor College of Medicine — Houston, Texas, United States (Recruiting)
• UZ Leuven — Leuven, Belgium (Recruiting)
• Hôpital Louis-Mourier — Colombes, France (Recruiting)
• Hôpital Edouard Herriot - CHU de Lyon — Lyon, France (Recruiting)
• CHU de Bordeaux — Pessac, France (Recruiting)
• CHU de Rouen — Rouen, France (Recruiting)
• Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden (Recruiting)
• University College London Hospital — London, United Kingdom (Recruiting)
• King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
• Manchester University NHS Foundation Trust — Manchester, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Timothy McAllister

Conditions Nausea; Vomiting; Chronic; Gastric Electrical Stimulation