Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enterra® Therapy System.
- Who it may be relevant to
- Registry conditions: Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
Overview
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.
Interventions
- 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.
Primary outcome measures
- Percent Change in Weekly Vomiting Frequency by GCSI-DD [Time frame: 3 Months, 6 Months]
- Scoring Change in Nausea Severity by GCSI-DD [Time frame: 3 Months, 6 Months]
Secondary outcome measures (5)
- Mean Change from Baseline in GCSI-DD Total Symptom Score [Time frame: 3 Months, 6 Months]
- Mean Change from Baseline in GCSI-DD Nausea Severity [Time frame: 3 Months, 6 Months]
- Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency [Time frame: 3 Months, 6 Months]
- Mean Change from Baseline in PAGI-QoL Scores [Time frame: 3 Months, 6 Months]
- Mean Change from Baseline in Quality of Sleep Scores [Time frame: 3 Months, 6 Months]
Eligibility criteria
In order to be eligible to participate in this study, a participant must meet all of the following criteria:
- Completed informed consent process with signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Male or female, aged ≥18 or ≤70 at time of informed consent;
- Currently implanted with the Enterra® Therapy System (Enterra® II 37800 neurostimulator);
- 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;
- Stable gastroparesis symptoms, in the opinion of the investigator;
- On stable medical therapy for gastroparesis symptoms;
- On stable supplemental nutritional support during the month prior to enrollment;
- English language comprehension to complete study-required assessments;
- 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:
- 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;
- Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night;
- Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning;
- Subjects without a regular and defined sleep schedule;
- Pregnancy, or subject that intends to become pregnant during participation in the study;
- Chemical dependency;
- Enterra lead impedance measurements ≥ 700 Ohms at screening visit;
- Life expectancy < 1 year from conditions other than GI diseases;
- Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications;
- Participation in other clinical studies;
- Subjects involved in current or past medical-related litigation;
- Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Louisville — Louisville
- MNGI Digestive Health, P.A. — Coon Rapids
Identifiers
NCT: NCT05980455 · CLN 001-PR-00755