Clinical trial NCT06560307: Study of Enhanced Programming Stimulation with the Enterra® Therapy System
Official title: Examination of Programming with the Enterra® Therapy System in a Double-Blinded, Randomized, Prospective Study in the Treatment of Nausea and Vomiting Symptoms Using Gastric Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroparesis
Gastroparesis Nondiabetic
Gastroparesis Due to Diabetes Mellitus
Keywords: Gastric electrical stimulation
Gastroparesis
Lead sponsor: Enterra Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Completed informed consent process with signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation
4. Diagnosed with idiopathic or diabetic gastroparesis
5. Delayed solid-phase gastric emptying study (Eggbeaters™ test meal), completed within one year of patient enrollment in the study. Gastroparesis defined as \> 60% retained at 2 hours and/or \>10% retained at 4 hours
6. Investigator confirms normal endoscopy within one year of enrollment in the study
7. GCSI-DD score for nausea severity during the qualifying Baseline Period averaging 2.5 or more per week and vomiting averaging 5 or more episodes per week

Exclusion Criteria:

1. Post-surgical gastroparesis (e.g., fundoplication, Billroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator
2. History of pyloroplasty or pyloromyotomy or G-POEM
3. Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study
4. Active H. pylori infection
5. Significant hepatic injury (elevated ALT, AST, bilirubin)
6. Metabolic, mechanical, or mucosal inflammatory causes that may explain GI symptoms such as gallbladder disease, small bowel bacterial overgrowth, IBS, inflammatory bowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction
7. Patients with significant cardiac or cardiovascular disease, malignancy, or other conditions
8. Participation in other clinical studies
9. Use of narcotics more than three days per week or other drugs that may affect motility (e.g., Glucagon-like peptide 1 (GLP-1) agonist drug)
10. Cannabis and/or cannabinoid use that exceeds either:

    1. Greater than 3 days of usage per week with 2 or less occurrences each day of use, or
    2. Greater than 3 grams of total usage per week
11. Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension
12. Subject experiences discomfort during stimulation assessment that cannot be tolerated
13. Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications
14. Evidence of a failed response to temporary gastric electrical stimulation

Primary outcomes:
measure: Change in Vomiting Absolute Frequency
timeFrame: 3 Months
measure: Change in Nausea Severity Score
timeFrame: 3 Months
Secondary outcomes:
measure: Change in Vomiting Absolute Frequency
timeFrame: 6 Months
measure: Change in Nausea Severity Score
timeFrame: 6 Months
measure: Change in Total Symptom Score
timeFrame: 3 Months
measure: Change in Total Symptom Score
timeFrame: 6 Months
measure: Change in Quality of Life Score
timeFrame: 3 Months
measure: Change in Quality of Life Score
timeFrame: 6 Months
measure: Change in Vomiting Absolute Frequency
timeFrame: 1 Month
measure: Change in Nausea Severity Score
timeFrame: 1 Month
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Portland
country: United States
facility: Foundation for Surgical Innovation
state: Oregon
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason
state: Washington
Study officials:
affiliation: Washington University School of Medicine
name: Michael Awad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: