Study of Enterra Programming with Nocturnal Cycling in Gastroparetics (RESTING)

Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroparesis; Gastroparesis Due to Diabetes Mellitus; Gastroparesis Nondiabetic
• Intervention / Treatment: Device: Enterra® Therapy System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothy McAllister; Phone Number: 855-768-3772; Email: clinicalresearch@enterramedical.com
• Study Contact Backup: Name: Jason Hamann, PhD; Phone Number: 855-768-3772; Email: clinicalresearch@enterramedical.com

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
      • Contact: Abigail Stocker, MD
      • Contact: Abigail Stocker, MD; Phone Number: 5025884600; Email: abigail.stocker@louisville.edu
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Recruiting
      • MNGI Digestive Health, P.A.
      • Contact: Roxanne Strehlo
      • Contact: April Grudell, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Weekly Vomiting Frequency by GCSI-DD	Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline	3 Months, 6 Months
Scoring Change in Nausea Severity by GCSI-DD	Less than a 1-point increase in GCSI-DD nausea severity from baseline	3 Months, 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in GCSI-DD Total Symptom Score	Change in GCSI-DD Total Symptom Score from baseline	3 Months, 6 Months
Mean Change from Baseline in GCSI-DD Nausea Severity	Change in GCSI-DD nausea severity from baseline	3 Months, 6 Months
Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency	Change in GCSI-DD weekly vomiting frequency from baseline	3 Months, 6 Months
Mean Change from Baseline in PAGI-QoL Scores	Change in PAGI-QoL from baseline	3 Months, 6 Months
Mean Change from Baseline in Quality of Sleep Scores	Change in Quality of Sleep from baseline	3 Months, 6 Months

Collaborators and Investigators

• Sponsor: Enterra Medical, Inc.
• Investigators: Principal Investigator: Abigail Stocker, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Gastroparesis; Gastric electrical stimulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: CLN 001-PR-00755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No