NCT06464926

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
5 countries

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jun 2025Jun 2030

First Submitted

Initial submission to the registry

June 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

June 23, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

June 13, 2024

Last Update Submit

April 7, 2026

Conditions

VomitingNausea

Keywords

ChronicNauseaVomitingGastric Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

    4 Months

Secondary Outcomes (10)

  • Change in Vomiting Absolute Frequency

    4 Months

  • Change in Nausea Severity Score

    12 Months

  • Change in Vomiting Absolute Frequency

    12 Months

  • Change in Total Symptom Score

    4 Months

  • Change in Total Symptom Score

    12 Months

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Device: Enterra Therapy System

Interventions

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.

OFF GroupON Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Hoag Hospital

Newport Beach, California, 92663, United States

RECRUITING

Sutter Health

San Francisco, California, 94109, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Endeavor Health

Evanston, Illinois, 60201, United States

RECRUITING

Indiana University Health

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Hackensack Meridian

Neptune City, New Jersey, 07753, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Temple Digestive Disease Center

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

Hôpital Louis-Mourier

Colombes, France

RECRUITING

Hôpital Edouard Herriot - CHU de Lyon

Lyon, 69003, France

RECRUITING

CHU de Bordeaux

Pessac, France

RECRUITING

CHU de Rouen

Rouen, 76031, France

RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

RECRUITING

University College London Hospital

London, NW1 6DB, United Kingdom

RECRUITING

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

RECRUITING

MeSH Terms

Conditions

NauseaVomitingBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Jason Hamann, PhD

    Enterra Medical, Inc.

    STUDY DIRECTOR

Central Study Contacts

Timothy McAllister

CONTACT

855-768-3772clinicalresearch@enterramedical.com

Hannah Bearinger, PhD

CONTACT

hannah.bearinger@brightresearch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Delegated site personnel will be unblinded to subject treatment assignments to appropriately program their Enterra Therapy System, per study requirements. Unblinded site personnel will be the only role delegated the responsibilities of randomizing subjects to a treatment assignment, performing device interrogations, and completing device programming at study visits according to the randomization assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 18, 2024

Study Start

June 23, 2025

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)SE(1)FR(4)US(11)BE(1)