RECRUITING

Study of Enhanced Programming Stimulation with the Enterra® Therapy System

Conditions

Gastroparesis Gastroparesis Nondiabetic Gastroparesis Due to Diabetes Mellitus Gastric electrical stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-07-25

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06560307

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Timothy McAllister

CONTACT

855-768-3772

clinicalresearch@enterramedical.com

Jason Hamann, PhD

CONTACT

855-768-3772

clinicalresearch@enterramedical.com

Principal Investigator

Michael Awad, MD, PhD

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

University of South Florida

Tampa, Florida, 33620

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Henry Ford Health System

Detroit, Michigan, 48202

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

Collaborators and Investigators

Sponsor: Enterra Medical, Inc.

Michael Awad, MD, PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-25

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-07-25

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Gastric electrical stimulation
Gastroparesis

Additional Relevant MeSH Terms

Gastroparesis
Gastroparesis Nondiabetic
Gastroparesis Due to Diabetes Mellitus