Study of Enhanced Programming Stimulation With the Enterra® Therapy System
NCT Number: NCT06560307
Acronym: EXPEDITE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastroparesis|Gastroparesis Nondiabetic|Gastroparesis Due to Diabetes Mellitus
Interventions: DEVICE: Enterra Therapy System
Sponsor: Enterra Medical, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2026-12
Locations: University of Louisville, Louisville, Kentucky, 40202, United States|Washington University, Saint Louis, Missouri, 63110, United States|Foundation for Surgical Innovation, Portland, Oregon, 97213, United States|Benaroya Research Institute at Virginia Mason, Seattle, Washington, 98101, United States

Summary:
The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures.

Participants in this study will be evaluated for study entry criteria, have an Enterra Therapy System implanted, and be randomly assigned to one of two programming strategies. 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 monthly 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.

Primary Outcome Measures: Change in Vomiting Absolute Frequency, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency, 3 Months|Change in Nausea Severity Score, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score, 3 Months
Secondary Outcome Measures: Change in Vomiting Absolute Frequency, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency, 6 Months|Change in Nausea Severity Score, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score, 6 Months|Change in Total Symptom Score, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score, 3 Months|Change in Total Symptom Score, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score, 6 Months|Change in Quality of Life Score, As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score, 3 Months|Change in Quality of Life Score, As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score, 6 Months|Change in Vomiting Absolute Frequency, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency, 1 Month|Change in Nausea Severity Score, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score, 1 Month