Enterra Programming for Gastroparesis
(RESTING Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Enterra Medical, Inc.
Disqualifiers: Post-surgical gastroparesis, Pregnancy, Chemical dependency, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that you are on stable medical therapy for gastroparesis symptoms. This suggests you may need to continue your current medications.
What data supports the effectiveness of the treatment Enterra Therapy System for gastroparesis?
Research shows that the Enterra Therapy System, which uses gastric electrical stimulation (GES), can improve symptoms like nausea and vomiting in patients with gastroparesis, including those with diabetic gastroparesis, for up to 10 years.
12345Eligibility Criteria
This trial is for adults aged 18-70 with gastroparesis who already have the Enterra™ Therapy System implanted and are on stable medical therapy. They should not have cognitive impairments, other GI diseases that explain symptoms, severe night-time nausea/vomiting, or an irregular sleep schedule. Pregnant individuals or those planning pregnancy during the study are excluded.Inclusion Criteria
I am willing and able to follow all study rules and attend all appointments.
Stable gastroparesis symptoms, in the opinion of the investigator
On stable supplemental nutritional support during the month prior to enrollment
+5 more
Exclusion Criteria
I often feel very nauseous or vomit at night.
Pregnancy, or subject that intends to become pregnant during participation in the study
I experience severe stomach emptying issues when I wake up.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomly assigned to one of three Enterra® device programming methods active during sleep, with daily symptom tracking and quality of life assessments.
6 months
Regular study visits for quality of life assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if different programming methods of the Enterra™ device during sleep can help maintain symptom relief and quality of life in people with gastroparesis. Participants will be randomly assigned to one of three programming methods and monitored for up to six months.
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 Sleep CycleExperimental Treatment1 Intervention
Device programming parameters participants have at enrollment will be used during waking hours.
During sleeping hours, the Enterra® device will cycle through modified programming over the course of 8 hours. Each hour, the Enterra® device will deliver 45 minutes of reduced stimulation, followed by 15 minutes of waking hours stimulation. At the end of the 8-hour sleep cycle, the Enterra® device will return to waking hours programming.
Group II: Arm 1 Sleep CycleExperimental Treatment1 Intervention
Device programming parameters participants have at enrollment will be used during waking hours.
During sleeping hours, the Enterra® device will cycle through modified programming over the course of 6 hours. Each hour, the Enterra® device will deliver 30 minutes of reduced stimulation, followed by 30 minutes of waking hours stimulation. At the end of the 6-hour sleep cycle, the Enterra® device will return to waking hours programming.
Group III: Control Sleep CycleActive Control1 Intervention
Baseline device programming parameters will be used during study participation. No modification to Enterra® device programming will be in effect during waking or sleeping hours.
Enterra™ Therapy System is already approved in United States for the following indications:
🇺🇸 Approved in United States as Enterra Therapy System for:
- Chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MNGI Digestive Health, P.A.Coon Rapids, MN
University of LouisvilleLouisville, KY
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Who Is Running the Clinical Trial?
Enterra Medical, Inc.Lead Sponsor
References
Gastric electrical stimulation improves outcomes of patients with gastroparesis for up to 10 years. [2022]We assessed the long-term clinical outcomes of gastric electrical stimulation (GES) therapy with Enterra (Enterra Therapy System; Medtronic, Minneapolis, MN) in a large cohort of patients with severe gastroparesis.
Is symptom relief associated with reduction in gastric retention after gastric electrical stimulation treatment in patients with gastroparesis? A sensitivity analysis with logistic regression models. [2012]Enterra gastric electrical stimulation (GES) is an alternative treatment for gastroparesis (GP) when standard medical therapy fails. The aims of this study were to evaluate the association between total symptom score (TSS) and reduction in gastric retention (GR) after GES by GP etiology and to examine the sensitivity of the association to varying cutpoints used to define GR and TSS improvement.
Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. [2022]Gastric electrical stimulation (GES) treats refractory gastroparesis by delivering electric current, via electrodes, to gastric smooth muscle. Enterra therapy (Medtronic, Inc, Minneapolis, MN) uses an implantable neurostimulator with a high-frequency, low-energy output. We performed a controlled, multicenter, prospective study to evaluate the safety and efficacy of Enterra therapy in patients with chronic intractable nausea and vomiting from diabetic gastroparesis (DGP).
An endoscopic wireless gastrostimulator (with video). [2023]Gastric electric stimulation (GES) at a high-frequency, low-energy setting is an option for treating refractory gastroparesis. The currently available commercial stimulator, the Enterra neurostimulator (Medtronic Inc, Minneapolis, MN), however, requires surgical implantation and is powered by a nonrechargeable battery.
Gastric neuromodulation with Enterra system for nausea and vomiting in patients with gastroparesis. [2022]Gastric electrical stimulation (GES) has been introduced for treating gastric motility disorders, such as gastroparesis, and obesity. A special method of GES using high frequency-short pulses, called Enterra® Therapy, has been clinically applied to treat nausea and vomiting in patients with gastroparesis. However, its mechanisms are not well understood.
A single arm, prospective, open label, multicentre study for evaluation of efficacy and safety of IV CERA for treatment of chronic renal anaemia in dialysis patients not currently treated with ESA. [2018]CERA, a continuous erythropoietin receptor activator, has reported effective correction of anaemia in international clinical trials.
Continuous erythropoiesis receptor activator (CERA) for the anaemia of chronic kidney disease. [2022]Continuous erythropoiesis receptor activator (CERA) is a newer, longer acting ESA which might be preferred to other ESAs (epoetin or darbepoetin) based on its lower frequency of administration. Different dosing requirements and molecular characteristics of CERA compared with other ESAs may lead to different health outcomes (mortality, cardiovascular events, quality of life) in people with anaemia and chronic kidney disease (CKD).
Cost-effectiveness of continuous erythropoietin receptor activator in anemia. [2021]Erythropoiesis-stimulating agents (ESAs) are the mainstay of anemia therapy. Continuous erythropoietin receptor activator (CERA) is a highly effective, long-acting ESA developed for once-monthly dosing. A multitude of clinical studies has evaluated the safety and efficiency of this treatment option for patients with renal anemia. In times of permanent financial pressure on health care systems, the cost-effectiveness of CERA should be of particular importance for payers and clinicians.
Synchronization of administrations of chemotherapy and erythropoiesis-stimulating agents and frequency of associated healthcare visits. [2021]The erythropoiesis-stimulating agents (ESAs), darbepoetin alfa (DA), and epoetin alfa (EA) differ with respect to dosing schedule in chemotherapy-induced anemia. DA can be administered less frequently than EA, which may increase synchronicity between chemotherapy and ESA schedules. This study compared DA and EA with respect to frequency of synchronization and frequencies of total and ESA healthcare visits in current clinical practice.
[QuiPO: who inject EPO?]. [2016]Erythropoiesis Stimulating Agents (ESA) are largely prescribed before dialysis stage to chronic kidney disease patients. In accordance to current international guidelines, lots have been made by pharmacological companies in order to improve self management of ESAs: subcutaneaous administration, pencil devices, mutidose cartridges, low injection volume, very fine needles, once a month injections but none is currently known on the percentage of patients who actually do self administration of ESAs.