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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.
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Inclusion criteria
Exclusion criteria
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
History of pyloroplasty or pyloromyotomy or G-POEM
Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study
Active H. pylori infection
Significant hepatic injury (elevated ALT, AST, bilirubin)
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
Patients with significant cardiac or cardiovascular disease, malignancy, or other conditions
Participation in other clinical studies
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)
Cannabis and/or cannabinoid use that exceeds either:
Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension
Subject experiences discomfort during stimulation assessment that cannot be tolerated
Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications
Evidence of a failed response to temporary gastric electrical stimulation
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
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Central trial contact
Timothy McAllister; Jason Hamann, PhD
Data sourced from clinicaltrials.gov
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