NCT05980455 · Enterra Medical, Inc.
Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
(RESTING)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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.
Where
- Louisville, Kentucky
- Coon Rapids, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 15, 2024 · Source of record for eligibility and locations