50 Participants Needed

Enterra Programming for Gastroparesis

(RESTING Trial)

Recruiting at 1 trial location
TM
JH
Overseen ByJason Hamann, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Enterra Medical, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Is Enterra Therapy safe for humans?

Enterra Therapy, which involves gastric electrical stimulation, has been studied for treating gastroparesis and has shown to be generally safe in humans, although it requires surgical implantation.12345

Is the Enterra™ Therapy System a promising treatment for gastroparesis?

The Enterra™ Therapy System is a promising treatment for gastroparesis because it offers a new way to help manage the symptoms of this condition.678910

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.12345

Who Is on the Research Team?

AS

Abigail Stocker, MD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

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
See 4 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.
See 9 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Enterra™ Therapy System
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 Sleep CycleExperimental Treatment1 Intervention
Group II: Arm 1 Sleep CycleExperimental Treatment1 Intervention
Group III: Control Sleep CycleActive Control1 Intervention

Enterra™ Therapy System is already approved in United States for the following indications:

🇺🇸
Approved in United States as Enterra Therapy System for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Enterra Medical, Inc.

Lead Sponsor

Trials
4
Recruited
300+

Published Research Related to This Trial

Gastric electrical stimulation (GES) therapy with the Enterra system significantly improved symptoms and reduced hospitalizations in 221 patients with severe gastroparesis over a mean follow-up of 56 months, demonstrating sustained efficacy for up to 10 years.
The therapy was well-tolerated, with a low rate of adverse events (7% of patients experienced infections at the device site), and led to weight gain and a reduction in medication use across all patient groups, particularly benefiting those with diabetic and postsurgical gastroparesis.
Gastric electrical stimulation improves outcomes of patients with gastroparesis for up to 10 years.McCallum, RW., Lin, Z., Forster, J., et al.[2022]
In a study of 221 patients with gastroparesis treated with Enterra gastric electrical stimulation (GES) for at least one year, significant symptom relief was observed in diabetic gastroparesis, which was consistently linked to reductions in gastric retention.
For idiopathic gastroparesis, the relationship between symptom improvement and gastric retention reduction was inconclusive, while no association was found for post-surgical gastroparesis, indicating that the effectiveness of GES may vary based on the underlying cause of the condition.
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.Hou, Q., Lin, Z., Mayo, MS., et al.[2012]
In a study of 55 patients with diabetic gastroparesis, gastric electrical stimulation (GES) using the Enterra system significantly reduced weekly vomiting frequency by 57% after 6 weeks and 67.8% after 1 year, indicating its efficacy in managing symptoms.
Patients also experienced improvements in overall symptom scores, gastric emptying, quality of life, and reduced hospital days, demonstrating the therapy's positive impact on both subjective and objective health measures.
Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study.McCallum, RW., Snape, W., Brody, F., et al.[2022]

Citations

Gastric electrical stimulation improves outcomes of patients with gastroparesis for up to 10 years. [2022]
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]
Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. [2022]
An endoscopic wireless gastrostimulator (with video). [2023]
Gastric neuromodulation with Enterra system for nausea and vomiting in patients with gastroparesis. [2022]
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]
Continuous erythropoiesis receptor activator (CERA) for the anaemia of chronic kidney disease. [2022]
Cost-effectiveness of continuous erythropoietin receptor activator in anemia. [2021]
Synchronization of administrations of chemotherapy and erythropoiesis-stimulating agents and frequency of associated healthcare visits. [2021]
[QuiPO: who inject EPO?]. [2016]
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