RecruitingNot ApplicableNCT05980455

Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics


Sponsor

Enterra Medical, Inc.

Enrollment

50 participants

Start Date

Jul 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures. Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. 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 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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Enterra® Therapy System for people with gastroparesis, gastroparesis due to diabetes mellitus, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEnterra® 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(2)

University of Louisville

Louisville, Kentucky, United States

MNGI Digestive Health, P.A.

Coon Rapids, Minnesota, United States

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NCT05980455


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