Study of Enhanced Programming Stimulation with the Enterra® Therapy System

NCT06560307 | Recruiting FDA Device

• 1 other identifier: CLN 001-PR-01218
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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.

Conditions

Gastroparesis; Gastroparesis Nondiabetic; Gastroparesis Due to Diabetes Mellitus

Keywords

Gastric electrical stimulation; Gastroparesis

Outcome Measures

Primary Outcomes (2)

• 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

  3 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

  3 Months

Secondary Outcomes (8)

• Change in Vomiting Absolute Frequency

  6 Months

• Change in Nausea Severity Score

  6 Months

• Change in Total Symptom Score

  3 Months

• Change in Total Symptom Score

  6 Months

• Change in Quality of Life Score

  3 Months

Study Arms (2)

Control Programming Stimulation

ACTIVE COMPARATOR

Begin with nominal (lower stimulation) programming settings at Enterra Therapy System implantation. At treatment assignment, nominal programming will continue. Slight increases in device amplitude (stimulation) will be done at 3 Month visit and at later follow-up visits.

Device: Enterra Therapy System

Enhanced Programming Stimulation

EXPERIMENTAL

Begin with nominal (lower stimulation) programming settings at Enterra Therapy System implantation. At treatment assignment, moderate increases in device amplitude (stimulation) and duty cycle (on/off cycles) will be done. Further adjustments to amplitude, duty cycle, and/or frequency (rate of pulses) will be done at follow-up visits.

Device: Enterra Therapy System

Interventions

Enterra Therapy System DEVICE

The Enterra® Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.

Also known as: Gastric electrical stimulation

Control Programming Stimulation; Enhanced Programming Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed informed consent process with signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration 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 within one year of patient enrollment in the study. Gastroparesis defined as \> 60% retained at 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

You may not qualify if:

• 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:
• Greater than 3 days of usage per week with 2 or less occurrences each day of use, 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 be tolerated
• Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications

Sponsors & Collaborators

• Enterra Medical, Inc.: lead

Study Sites (6)

University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Foundation for Surgical Innovation

Portland, Oregon, 97213, United States

RECRUITING

Benaroya Research Institute at Virginia Mason

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Awad, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy McAllister

CONTACT

855-768-3772; clinicalresearch@enterramedical.com

Jason Hamann, PhD

CONTACT

855-768-3772; clinicalresearch@enterramedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)