BridgeMD
New treatment option for Gastroparesis
Official title Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
ClinicalTrials.gov ID: NCT05980455
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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);
See the full 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;
- people, in the opinion of the investigator, with profound nausea and/or vomiting at night;
- people, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning;
- people 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;
- people with an underlying disease leading to follow-up by MRI outside of current MR conditional indications;
- Participation in other clinical studies;
- people involved in current or past medical-related litigation;
- people with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
- Coon Rapids, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States; Coon Rapids, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.