Phase
Condition
Gastroparesis
Treatment
Enterra Therapy System
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Completed informed consent process with signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for theduration of the study
Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation
Diagnosed with idiopathic or diabetic gastroparesis
Delayed solid-phase gastric emptying study (Eggbeaters™ test meal), completed withinone year of patient enrollment in the study. Gastroparesis defined as > 60% retainedat 2 hours and/or >10% retained at 4 hours
Investigator confirms normal endoscopy within one year of enrollment in the study
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
Exclusion Criteria:
Post-surgical gastroparesis (e.g., fundoplication, Billroth I or II) or other activestomach or gastrointestinal diseases disorders which could explain symptoms in theopinion of the investigator
History of pyloroplasty or pyloromyotomy or G-POEM
Pregnancy or breastfeeding at the time of consent, or intent to become pregnantduring the study
Active H. pylori infection
Significant hepatic injury (elevated ALT, AST, bilirubin)
Metabolic, mechanical, or mucosal inflammatory causes that may explain GI symptomssuch as gallbladder disease, small bowel bacterial overgrowth, IBS, inflammatorybowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction
Patients with significant cardiac or cardiovascular disease, malignancy, or otherconditions
Participation in other clinical studies
Use of narcotics more than three days per week or other drugs that may affectmotility (e.g., Glucagon-like peptide 1 (GLP-1) agonist drug)
Cannabis and/or cannabinoid use that exceeds either:
Greater than 3 days of usage per week with 2 or less occurrences each day ofuse, or
Greater than 3 grams of total usage per week
Previous diagnosis or history of orthostatic intolerance, e.g., POTS,neurocardiogenic syncope, orthostatic hypotension
Subject experiences discomfort during stimulation assessment that cannot betolerated
Subjects with an underlying disease leading to follow-up by MRI outside of currentMR conditional indications
Evidence of a failed response to temporary gastric electrical stimulation
Study Design
Connect with a study center
University of South Florida
Tampa, Florida 33620
United StatesActive - Recruiting
University of Louisville
Louisville, Kentucky 40202
United StatesActive - Recruiting
Henry Ford Health System
Detroit, Michigan 48202
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Foundation for Surgical Innovation
Portland, Oregon 97213
United StatesActive - Recruiting
Benaroya Research Institute at Virginia Mason
Seattle, Washington 98101
United StatesActive - Recruiting
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