Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Not Applicable

Recruiting

• Conditions: Gastroparesis Nondiabetic; Gastroparesis; Gastroparesis Due to Diabetes Mellitus
• Interventions: Device: Enterra® Therapy System

• Registration Number: NCT05980455
• Lead Sponsor: Enterra Medical, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-10
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Sleep Cycle	Enterra® Therapy System	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.
Arm 2 Sleep Cycle	Enterra® Therapy System	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.
Arm 1 Sleep Cycle	Enterra® Therapy System	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.

Primary Outcome Measures

Name	Time	Method
Scoring Change in Nausea Severity by GCSI-DD	3 Months, 6 Months	Less than a 1-point increase in GCSI-DD nausea severity from baseline
Percent Change in Weekly Vomiting Frequency by GCSI-DD	3 Months, 6 Months	Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline

Secondary Outcome Measures

Name	Time	Method
Mean Change from Baseline in GCSI-DD Total Symptom Score	3 Months, 6 Months	Change in GCSI-DD Total Symptom Score from baseline
Mean Change from Baseline in GCSI-DD Nausea Severity	3 Months, 6 Months	Change in GCSI-DD nausea severity from baseline
Mean Change from Baseline in PAGI-QoL Scores	3 Months, 6 Months	Change in PAGI-QoL from baseline
Mean Change from Baseline in Quality of Sleep Scores	3 Months, 6 Months	Change in Quality of Sleep from baseline
Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency	3 Months, 6 Months	Change in GCSI-DD weekly vomiting frequency from baseline

Trial Locations

Locations (2)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

MNGI Digestive Health, P.A.; 🇺🇸 Coon Rapids, Minnesota, United States