Enterra Therapy System for Gastroparesis

(EXPEDITE Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Michael Awad, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Enterra Medical, Inc.

Must not be taking: Narcotics, GLP-1 agonists

Disqualifiers: Post-surgical gastroparesis, Pregnancy, Hepatic injury, 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 an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures. Participants in this study will be evaluated for study entry criteria, have an Enterra Therapy System implanted, and be randomly assigned to one of two programming strategies. 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 monthly 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 does exclude those using narcotics more than three days a week or drugs that affect stomach movement. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the Enterra Therapy System treatment for gastroparesis?

Research shows that the Enterra Therapy System, which uses electrical pulses to help the stomach muscles work better, can improve symptoms and quality of life for people with severe gastroparesis, including those with diabetic gastroparesis. Studies have found that it can help reduce nausea and vomiting and improve stomach emptying over the long term.

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How does the Enterra Therapy System treatment for gastroparesis differ from other treatments?

The Enterra Therapy System is unique because it uses a small device implanted in the body to deliver electrical pulses to the stomach, helping to improve stomach muscle function and reduce symptoms like nausea and vomiting, especially when other treatments have failed.

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Eligibility Criteria

This trial is for individuals with gastroparesis, a condition where the stomach takes too long to empty its contents. Participants will have an Enterra Therapy System implanted and must be willing to use an app daily to track symptoms and attend monthly visits for up to six months.

Inclusion Criteria

I am willing and able to follow all study requirements.

I have a confirmed diagnosis of gastroparesis from a test done within the last year.

Investigator confirms normal endoscopy within one year of enrollment in the study

Exclusion Criteria

Active H. pylori infection

My liver tests (ALT, AST, bilirubin) are not significantly high.

Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants have an Enterra Therapy System implanted and are randomly assigned to one of two programming strategies. They answer daily questions about their symptoms and complete quality of life questionnaires at monthly visits.

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for changes in symptom scores and quality of life measures after treatment

4 weeks

Participant Groups

The study tests whether a new programming strategy for the Enterra Therapy System can better alleviate gastroparesis symptoms, speed up relief, and improve quality of life compared to standard programming. Patients are randomly assigned one of two strategies.

Group I: Enhanced Programming Stimulation Experimental Treatment 1 Intervention

Begin with nominal (lower stimulation) programming settings at Enterra Therapy System implantation. At treatment assignment, moderate increases in device amplitude (stimulation) and duty cycle (on/off cycles) will be done. Further adjustments to amplitude, duty cycle, and/or frequency (rate of pulses) will be done at follow-up visits.

Group II: Control Programming Stimulation Active Control 1 Intervention

Begin with nominal (lower stimulation) programming settings at Enterra Therapy System implantation. At treatment assignment, nominal programming will continue. Slight increases in device amplitude (stimulation) will be done at 3 Month visit and at later follow-up visits.

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

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

• Chronic, intractable nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Benaroya Research Institute at Virginia Mason Seattle, WA

University of Louisville Louisville, KY

Washington University Saint Louis, MO

Foundation for Surgical Innovation Portland, OR

More Trial Locations

Who Is Running the Clinical Trial?

Enterra Medical, Inc. Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of gastric neurostimulation in patients with gastroparesis. [2020] Patients with gastroparesis have significantly delayed gastric emptying because of impaired nerve function. Gastric neurostimulation from Enterra Therapy provides electrical pulses to the stomach tissue that promotes stimulation of stomach smooth muscle, thereby enhancing gastric emptying. This study evaluates the effectiveness of Enterra Therapy (Medtronic, Minneapolis, Minnesota) in reducing symptoms and improving the quality of life of patients with drug-refractory gastroparesis.

3. United States pubmed.ncbi.nlm.nih.gov

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).

4. England pubmed.ncbi.nlm.nih.gov

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.

5. United States pubmed.ncbi.nlm.nih.gov

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.

6. England pubmed.ncbi.nlm.nih.gov

Enterra Therapy: gastric neurostimulator for gastroparesis. [2010] Gastroparesis is a chronic disorder of gastric motility characterized by delayed gastric empting in the absence of mechanical obstruction, which can lead to symptoms of nausea, vomiting, bloating, abdominal pain, postprandial fullness and weight loss. Although there are many etiologies, the primary causes are diabetes or are idiopathic. The mainstay of treatment is dietary and drug therapies. However, many patients will continue to suffer intractable symptoms despite these treatments. Gastric neurostimulation with the Enterra Therapy system has been approved for use under the Humanitarian Device Exemption by the US FDA. The device produces pulses of electrical stimulation that are delivered to the stomach continuously. One randomized clinical trial and multiple nonrandomized unblinded clinical trials and case series have documented improvement of symptoms in intractable diabetic and idiopathic gastroparesis. The purpose of this article is to introduce the Enterra Therapy gastric neurostimulator. Gastroparesis and its pathophysiology will be discussed in this clinical context to enhance the understanding of the device and its development. We will analyze the device in detail, its placement and the results of studies evaluating its efficacy.