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Studies

Interventional Recruiting

NCT06464926 on ClinicalTrials.gov

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

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

  • Sponsor: Enterra Medical, Inc.
  • Collaborators: Bright Research Partners
  • Enrollment: 148 (Estimated)
  • Study start: 2025-06-23 (Actual)
  • Primary completion: 2030-06-01 (Estimated)
  • Study completion: 2030-06-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 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.
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Device: Enterra Therapy System

Primary Outcome Measures

  • Change in Nausea Severity Score (4 Months)
    As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score

Countries

Belgium, France, Sweden, United Kingdom, United States

Locations and Investigators

  • Mayo Clinic Arizona, Scottsdale, United States (Recruiting)
    • Aubrey Smith
    • Alexandria Ramirez
    • William Hasler, MD (Principal Investigator)
  • Keck Medicine of USC, Los Angeles, United States (Recruiting)
    • Caitlin Houghton, MD (Principal Investigator)
  • Hoag Hospital, Newport Beach, United States (Recruiting)
    • Christy Dunst, MD (Principal Investigator)
  • Sutter Health, San Francisco, United States (Recruiting)
    • Stefanie Roberts
    • Christie Linh
    • Mimi Lin, MD (Principal Investigator)
  • University of South Florida, Tampa, United States (Recruiting)
    • Ilexsius Fiorillo
    • Beth Montera
    • Joseph Sujka, MD (Principal Investigator)
  • Endeavor Health, Evanston, United States (Recruiting)
    • Herbert M Hedberg, MD (Principal Investigator)
  • Indiana University Health, Indianapolis, United States (Recruiting)
    • Maureen Schilling
    • Thomas Nowak, MD (Principal Investigator)
    • John Wo, MD
  • University of Louisville, Louisville, United States (Recruiting)
    • Amy Perdue, RN
    • Abigail Stocker, MD
    • Abigail Stocker, MD (Principal Investigator)
    • Carmelita Moppins, APRN
    • Lindsay McElmurray, PA-C
  • Hackensack Meridian, Neptune City, United States (Recruiting)
    • Seth Kipnis, MD (Principal Investigator)
  • Cleveland Clinic Foundation, Cleveland, United States (Recruiting)
    • Anthony Lembo, MD (Principal Investigator)
  • Temple Digestive Disease Center, Philadelphia, United States (Recruiting)
    • Alexis Bailey
    • Henry P Parkman, MD (Principal Investigator)
  • Baylor College of Medicine, Houston, United States (Recruiting)
    • Reena Chokshi, MD (Principal Investigator)
  • UZ Leuven, Leuven, Belgium (Recruiting)
    • Jan Tack, MD/PhD (Principal Investigator)
  • Hôpital Louis-Mourier, Colombes, France (Recruiting)
    • Heithem Soliman, MD (Principal Investigator)
  • Hôpital Edouard Herriot - CHU de Lyon, Lyon, France (Recruiting)
    • François Mion, MD (Principal Investigator)
  • CHU de Bordeaux, Pessac, France (Recruiting)
  • CHU de Rouen, Rouen, France (Recruiting)
    • Guillaume Gourcerol (Principal Investigator)
    • Charlotte Desprez
    • Chloé Melchior
  • Sahlgrenska Universitetssjukhuset, Gothenburg, Sweden (Recruiting)
    • Hans Törnblom, MD, PhD (Principal Investigator)
  • University College London Hospital, London, United Kingdom (Recruiting)
    • Natalia Zarate-Lopez, PhD (Principal Investigator)
  • King's College Hospital NHS Foundation Trust, London, United Kingdom (Recruiting)
    • Bu'Hussain Hayee, PhD (Principal Investigator)
  • Manchester University NHS Foundation Trust, Manchester, United Kingdom (Recruiting)
    • Dipesh Vasant, PhD (Principal Investigator)
  • Functional Gut Clinic, Manchester, United Kingdom (Recruiting)
    • Paul Goldsmith, MD (Principal Investigator)

Study Officials

  • Jason Hamann, PhD (Study Director) — Enterra Medical, Inc.