Clinical trial NCT05980455: Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
Official title: Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroparesis
Gastroparesis Nondiabetic
Gastroparesis Due to Diabetes Mellitus
Keywords: Gastric electrical stimulation
Gastroparesis
Lead sponsor: Enterra Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percent Change in Weekly Vomiting Frequency by GCSI-DD
timeFrame: 3 Months, 6 Months
measure: Scoring Change in Nausea Severity by GCSI-DD
timeFrame: 3 Months, 6 Months
Secondary outcomes:
measure: Mean Change from Baseline in GCSI-DD Total Symptom Score
timeFrame: 3 Months, 6 Months
measure: Mean Change from Baseline in GCSI-DD Nausea Severity
timeFrame: 3 Months, 6 Months
measure: Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency
timeFrame: 3 Months, 6 Months
measure: Mean Change from Baseline in PAGI-QoL Scores
timeFrame: 3 Months, 6 Months
measure: Mean Change from Baseline in Quality of Sleep Scores
timeFrame: 3 Months, 6 Months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Coon Rapids
country: United States
facility: MNGI Digestive Health, P.A.
state: Minnesota
Study officials:
affiliation: University of Louisville
name: Abigail Stocker, MD
role: PRINCIPAL_INVESTIGATOR
References: