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RECRUITING
NCT05980455
NA

Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Sponsor: Enterra Medical, Inc.

View on ClinicalTrials.gov

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.

Official title: Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-07-10

Completion Date

2025-12

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 (2)

University of Louisville

Louisville, Kentucky, United States

MNGI Digestive Health, P.A.

Coon Rapids, Minnesota, United States