Recruiting

Enterra® Therapy

Sponsor:

Enterra Medical, Inc.

Code:

NCT06464926

Conditions

Nausea

Vomiting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enterra Therapy System

Study Details

Brief 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.

Conditions

Nausea

Vomiting

Study ID

NCT06464926

Start date

Jun 23, 2025

Status verified date

May, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Change in Nausea Severity Score [ Time Frame: 4 Months ]

Central Contacts and Locations

Central contacts

Timothy McAllister

855-768-3772clinicalresearch@enterramedical.com

Hannah Bearinger, PhD

hannah.bearinger@brightresearch.com

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Aubrey Smith

Smith.Aubrey@mayo.edu

Alexandria Ramirez

Ramirez.Alexandria@mayo.edu

Principal Investigator:

William Hasler, MD

Keck Medicine of USC

Recruiting

Los Angeles, California, United States, 90033

Principal Investigator:

Caitlin Houghton, MD

Hoag Hospital

Recruiting

Newport Beach, California, United States, 92663

Principal Investigator:

Christy Dunst, MD

Sutter Health

Recruiting

San Francisco, California, United States, 94109

Contacts

Stefanie Roberts

415-600-1107Stefanie.roberts@sutterhealth.org

Christie Linh

415-600-5764Christie.linh@sutterhealth.org

Principal Investigator:

Mimi Lin, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Ilexsius Fiorillo

813-844-7650ilexsius@usf.edu

Beth Montera

813-844-7948bmontera@usf.edu

Principal Investigator:

Joseph Sujka, MD

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Principal Investigator:

Herbert M Hedberg, MD

Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Maureen Schilling

317-278-2064maschi@iu.edu

Principal Investigator:

Thomas Nowak, MD

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Amy Perdue, RN

502-560-8413amy.perdue@louisville.edu

Abigail Stocker, MD

abigail.stocker@louisville.edu

Principal Investigator:

Abigail Stocker, MD

Hackensack Meridian

Recruiting

Neptune City, New Jersey, United States, 07753

Principal Investigator:

Seth Kipnis, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Anthony Lembo, MD

Temple Digestive Disease Center

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Alexis Bailey

215-707-7340alexis.bailey1@temple.edu

Principal Investigator:

Henry P Parkman, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Reena Chokshi, MD

More Information

Sponsor

Enterra Medical, Inc.

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Chronic
  • Nausea
  • Vomiting
  • Gastric Electrical Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Enterra Medical, Inc. on 2026-05-14.