Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

NCT ID: NCT05980455

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures.

Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Sleep Cycle

Baseline device programming parameters will be used during study participation. No modification to Enterra® device programming will be in effect during waking or sleeping hours.

Group Type: ACTIVE_COMPARATOR

Enterra® Therapy System

Intervention Type: 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.

Arm 1 Sleep Cycle

Device programming parameters participants have at enrollment will be used during waking hours.

During sleeping hours, the Enterra® device will cycle through modified programming over the course of 6 hours. Each hour, the Enterra® device will deliver 30 minutes of reduced stimulation, followed by 30 minutes of waking hours stimulation. At the end of the 6-hour sleep cycle, the Enterra® device will return to waking hours programming.

Group Type: EXPERIMENTAL

Enterra® Therapy System

Intervention Type: 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.

Arm 2 Sleep Cycle

Device programming parameters participants have at enrollment will be used during waking hours.

During sleeping hours, the Enterra® device will cycle through modified programming over the course of 8 hours. Each hour, the Enterra® device will deliver 45 minutes of reduced stimulation, followed by 15 minutes of waking hours stimulation. At the end of the 8-hour sleep cycle, the Enterra® device will return to waking hours programming.

Group Type: EXPERIMENTAL

Enterra® Therapy System

Intervention Type: 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.

Interventions

Enterra® Therapy System

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.

Intervention Type: DEVICE

Other Intervention Names

Gastric electrical stimulation

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 at time of informed consent;

4. Currently implanted with the Enterra® Therapy System (Enterra® II 37800 neurostimulator);

5. High GES output defined as remaining pulse generator expected life of > 9 months from enrollment and less than 4 years from the time of implant;

6. Stable gastroparesis symptoms, in the opinion of the investigator;

7. On stable medical therapy for gastroparesis symptoms;

8. On stable supplemental nutritional support during the month prior to enrollment;

9. English language comprehension to complete study-required assessments;

10. Reliable access to internet-connected smart device(s) to complete study-required assessments.

A participant who meets any of the following criteria will be excluded from participation in this study:

1. Post-surgical gastroparesis (e.g., fundoplication, Bilroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator;

2. Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night;

3. Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning;

4. Subjects without a regular and defined sleep schedule;

5. Pregnancy, or subject that intends to become pregnant during participation in the study;

6. Chemical dependency;

7. Enterra lead impedance measurements ≥ 700 Ohms at screening visit;

8. Life expectancy < 1 year from conditions other than GI diseases;

9. Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications;

10. Participation in other clinical studies;

11. Subjects involved in current or past medical-related litigation;

12. Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enterra Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abigail Stocker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Site Status: RECRUITING

MNGI Digestive Health, P.A.

Coon Rapids, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Timothy McAllister

Role: CONTACT

clinicalresearch@enterramedical.com

855-768-3772

Jason Hamann, PhD

Role: CONTACT

clinicalresearch@enterramedical.com

855-768-3772

Facility Contacts

Abigail Stocker, MD

Role: primary

abigail.stocker@louisville.edu

5025884600

Abigail Stocker, MD

Role: backup

Roxanne Strehlo

Role: primary

April Grudell, MD

Role: backup

Other Identifiers

CLN 001-PR-00755

Identifier Type: -

Identifier Source: org_study_id