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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Enterra Medical, Inc.
Study ID
NCT06464926
Status
Recruiting
Apply to this trial

Conditions

  • Nausea
  • Vomiting

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enterra Therapy System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 23, 2025
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259
Aubrey Smith
[email protected]
Alexandria Ramirez
[email protected]
William Hasler, MD (PRINCIPAL_INVESTIGATOR)
Keck Medicine of USCLos AngelesCalifornia90033
Caitlin Houghton, MD (PRINCIPAL_INVESTIGATOR)
Hoag HospitalNewport BeachCalifornia92663
Christy Dunst, MD (PRINCIPAL_INVESTIGATOR)
Sutter HealthSan FranciscoCalifornia94109
Stefanie Roberts
[email protected]
415-600-1107
Christie Linh
[email protected]
415-600-5764
Mimi Lin, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33606
Ilexsius Fiorillo
[email protected]
813-844-7650
Beth Montera
[email protected]
813-844-7948
Joseph Sujka, MD (PRINCIPAL_INVESTIGATOR)
Endeavor HealthEvanstonIllinois60201
Herbert M Hedberg, MD (PRINCIPAL_INVESTIGATOR)
Indiana University HealthIndianapolisIndiana46202
Maureen Schilling
[email protected]
317-278-2064
Thomas Nowak, MD (PRINCIPAL_INVESTIGATOR)
John Wo, MD (SUB_INVESTIGATOR)
University of LouisvilleLouisvilleKentucky40202
Amy Perdue, RN
[email protected]
502-560-8413
Abigail Stocker, MD
[email protected]
Abigail Stocker, MD (PRINCIPAL_INVESTIGATOR)
Carmelita Moppins, APRN (SUB_INVESTIGATOR)
Lindsay McElmurray, PA-C (SUB_INVESTIGATOR)
Hackensack MeridianNeptune CityNew Jersey07753
Seth Kipnis, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Anthony Lembo, MD (PRINCIPAL_INVESTIGATOR)
Temple Digestive Disease CenterPhiladelphiaPennsylvania19140
Alexis Bailey
[email protected]
215-707-7340
Henry P Parkman, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Reena Chokshi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic Arizona· Scottsdale, AZKeck Medicine of USC· Los Angeles, CAHoag Hospital· Newport Beach, CASutter Health· San Francisco, CAUniversity of South Florida· Tampa, FLEndeavor Health· Evanston, IL

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