Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Enterra Medical, Inc.
Study ID
NCT05980455
Status
Recruiting
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Conditions

  • Gastroparesis
  • Gastroparesis Due to Diabetes Mellitus
  • Gastroparesis Nondiabetic

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Enterra® Therapy System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 10, 2023
Status verified
Nov 2024
Primary completion
Aug 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Sleep Cycle
    Baseline device programming parameters will be used during study participation. No modification to Enterra® device programming will be in effect during waking or sleeping hours.
  • Experimental: Arm 1 Sleep Cycle
    Device programming parameters participants have at enrollment will be used during waking hours. During sleeping hours, the Enterra® device will cycle through modified programming over the course of 6 hours. Each hour, the Enterra® device will deliver 30 minutes of reduced stimulation, followed by 30 minutes of waking hours stimulation. At the end of the 6-hour sleep cycle, the Enterra® device will return to waking hours programming.
  • Experimental: Arm 2 Sleep Cycle
    Device programming parameters participants have at enrollment will be used during waking hours. During sleeping hours, the Enterra® device will cycle through modified programming over the course of 8 hours. Each hour, the Enterra® device will deliver 45 minutes of reduced stimulation, followed by 15 minutes of waking hours stimulation. At the end of the 8-hour sleep cycle, the Enterra® device will return to waking hours programming.

Primary Outcome Measure

Percent Change in Weekly Vomiting Frequency by GCSI-DD [ Time Frame: 3 Months, 6 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Abigail Stocker, MD
[email protected]
5025884600
Abigail Stocker, MD
MNGI Digestive Health, P.A.Coon RapidsMinnesota55433
Roxanne Strehlo
April Grudell, MD

Find similar trials in Louisville, KY

By research site
University of Louisville· Louisville, KYMNGI Digestive Health, P.A.· Coon Rapids, MN

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