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RECRUITING
NCT06560307
NA

Study of Enhanced Programming Stimulation with the Enterra® Therapy System

Sponsor: Enterra Medical, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures. Participants in this study will be evaluated for study entry criteria, have an Enterra Therapy System implanted, and be randomly assigned to one of two programming strategies. Participants will answer daily questions about their gastroparesis symptoms on an application with their phone/tablet. Participants will answer quality of life questionnaires about their gastroparesis symptoms at monthly study visits. Participants will be involved in the study for up to six months after treatment assignment. Programming parameters in the study are within currently approved labeling.

Official title: Examination of Programming with the Enterra® Therapy System in a Double-Blinded, Randomized, Prospective Study in the Treatment of Nausea and Vomiting Symptoms Using Gastric Electrical Stimulation

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-07-25

Completion Date

2026-12

Last Updated

2024-11-15

Healthy Volunteers

No

Interventions

DEVICE

Enterra Therapy System

The Enterra® Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.

Locations (6)

University of South Florida

Tampa, Florida, United States

University of Louisville

Louisville, Kentucky, United States

Henry Ford Health System

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Foundation for Surgical Innovation

Portland, Oregon, United States

Benaroya Research Institute at Virginia Mason

Seattle, Washington, United States