Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Description

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.

Conditions

Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus

Study Overview

Study Details

Study overview

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.

Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Condition
Gastroparesis
Intervention / Treatment

-

Contacts and Locations

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

Coon Rapids

MNGI Digestive Health, P.A., Coon Rapids, Minnesota, United States, 55433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to 70 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Enterra Medical, Inc.,

    Abigail Stocker, MD, PRINCIPAL_INVESTIGATOR, University of Louisville

    Study Record Dates

    2025-12