Study of Enterra Programming With Nocturnal Cycling in Gastroparetics

Gastroparesis Clinical Trial

— RESTING  

Official title:

Randomized Study of Enterra Programming With Nocturnal Cycling in Gastroparetics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980455
• Other study ID #: CLN 001-PR-00755
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Enterra Medical, Inc.
• Contact: Timothy McAllister
• Phone: 855-768-3772
• Email: clinicalresearch[@]enterramedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroparesis
• Gastroparesis Due to Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	MNGI Digestive Health, P.A.	Coon Rapids	Minnesota
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Enterra Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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