Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)
NCT Number: NCT06464926
Acronym: NAVIGATE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nausea|Vomiting
Interventions: DEVICE: Enterra Therapy System
Sponsor: Enterra Medical, Inc.
Collaborators: Bright Research Partners
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 148
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-12

Summary:
The purpose of this research study is to determine if the Enterra® Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea, with or without vomiting, that have normal gastric emptying.

Primary Outcome Measures: 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, 4 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. Analysis only performed if ≥64 evaluable participants have a baseline weekly vomiting frequency of ≥5 per week, 4 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, 12 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. Analysis only performed if ≥64 evaluable participants have a baseline weekly vomiting frequency of ≥5 per week, 12 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, 4 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, 12 Months|Change in Quality of Life Score, As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score, 12 Months|Change in Quality of Life Score, As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score, 4 Months|Change in Early Satiety Score, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) early satiety score, 4 Months|Change in Postprandial Fullness Score, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) postprandial fullness score, 4 Months|Change in Abdominal Pain Score, As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) abdominal pain score, 4 Months