Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

In order to be eligible to participate in this study, a participant must meet all of the
following 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • Device: 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.
    Other names:
    • Gastric electrical stimulation
Experimental
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.
  • Device: 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.
    Other names:
    • Gastric electrical stimulation
Experimental
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.
  • Device: 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.
    Other names:
    • Gastric electrical stimulation

Recruiting Locations

University of Louisville
Louisville, Kentucky 40202
Contact:
Abigail Stocker, MD
5025884600
abigail.stocker@louisville.edu

MNGI Digestive Health, P.A.
Coon Rapids, Minnesota 55433
Contact:
Roxanne Strehlo

More Details

Status
Recruiting
Sponsor
Enterra Medical, Inc.

Study Contact

Timothy McAllister
855-768-3772
clinicalresearch@enterramedical.com