NCT05980455

Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Enterra Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroparesis
• Gastroparesis Nondiabetic
• Gastroparesis Due to Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-10
• Primary completion: 2025-08-01
• Completion: 2025-12-01
• First posted: 2023-08-08
• Last updated: 2024-11-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study