Neurostimulator for Gastroparesis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Methodist Health System

Disqualifiers: Organ transplant, Gastric surgery, Seizures, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Enterra II Neurostimulator to help people with gastroparesis, a condition causing severe nausea and vomiting due to improper stomach emptying. The goal is to determine if this device can reduce symptoms when medication proves ineffective. It suits those with persistent nausea and vomiting from diabetic or unknown causes of gastroparesis. As an unphased trial, this study provides an opportunity for patients to explore new treatment options when other methods have failed.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Enterra II Neurostimulator is safe for treating gastroparesis?

Previous studies have shown that the Enterra II Neurostimulator helps reduce nausea and vomiting in people with gastroparesis, a condition where the stomach empties its contents too slowly. The FDA has already approved the device for this purpose, indicating it is generally considered safe.

Safety data reviewed by the FDA shows that most patients tolerate the device well. Some people might experience minor side effects like skin irritation or pain where the device is placed. However, serious complications are rare. Discussing potential risks and benefits with a doctor is important before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Enterra II Neurostimulator is unique because it provides a new approach to managing gastroparesis by using electrical stimulation to influence stomach muscles and nerves. Traditional treatments often involve dietary changes, medications that enhance stomach motility, or even surgery, but they can have limited effectiveness or significant side effects. The Enterra II is exciting because it is powered by a specialized battery and encased in a titanium shield to prevent interaction with muscle tissue, potentially offering a more precise and less invasive way to alleviate symptoms. Researchers are particularly interested in its ability to target the nervous system directly, which could lead to better symptom control and improved quality of life for patients.

What evidence suggests that the Enterra II Neurostimulator is effective for gastroparesis?

Research has shown that the Enterra II Neurostimulator, which participants in this trial will receive, can help reduce symptoms of gastroparesis. Studies have found that patients using this device experienced significant improvement in symptoms like nausea and vomiting. This therapy enhances the quality of life for people with gastroparesis, especially when other treatments have failed. It sends gentle electrical signals to the stomach, helping to control nausea and vomiting. This device is specifically designed for those with gastroparesis caused by diabetes or unknown reasons. ^{2 3 6 7 8}

Who Is on the Research Team?

Sachin Kukreja, MD

Principal Investigator

Methodist Heath System

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 70 with severe, ongoing nausea and vomiting due to gastroparesis that hasn't improved with medication. It's not suitable for those who've had organ transplants, gastric surgery, certain other medical conditions like scleroderma or amyloidosis, seizures, are on dialysis, pregnant women, or individuals with eating disorders.

Exclusion Criteria

I have had surgery on my stomach before.

I have a history of seizures.

I experience vomiting that's caused by stress or mental factors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Medtronic Enterra II Neurostimulator to treat chronic intractable nausea and vomiting

Up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enterra II Neurostimulator

Trial Overview The Medtronic Enterra II Neurostimulator (Enterra HDE) is being tested. This device is approved in the U.S. specifically for treating chronic nausea and vomiting caused by gastroparesis when medications don't work.

How Is the Trial Designed?

Group I: The Medtronic Enterra II Model 37800 Neurostimulator Experimental Treatment 1 Intervention

It is powered by a hermetically sealed hybrid cathode silver vanadium oxide (HCSVO) single-cell battery. To further protect the neurostimulator components from body fluids, the electronics and power source are hermetically sealed within an oval-shaped titanium shield. The neurostimulator case has an external insulating coating to prevent skeletal muscle stimulation at the neurostimulator implant site. An uninsulated area on one side of the neurostimulator (etched identification side) forms the indifferent electrode. The uninsulated side should be positioned away from muscle tissue. The neurostimulator has a self-sealing connector assembly with a corrosion-resistant titanium alloy body \& titanium setscrews. Securing the lead system requires the use of a torque wrench which is packaged with the neurostimulator.

Who Is Running the Clinical Trial?

Methodist Health System

Lead Sponsor

Trials

156

Recruited

4,826,000+

Published Research Related to This Trial

A new miniature wireless gastric electric stimulation (GES) device was successfully tested in a nonsurvival swine model, showing that it can be implanted endoscopically, which is less invasive than traditional surgical methods.

Stimulation with the wireless GES device resulted in more regular gastric slow waves and consistent amplitudes, indicating its potential effectiveness in treating refractory gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An endoscopic wireless gastrostimulator (with video). Deb, S., Tang, SJ., Abell, TL., et al.[2023]

The Enterra Therapy gastric neurostimulator has been approved by the FDA for treating intractable gastroparesis, a condition characterized by delayed gastric emptying, particularly in patients with diabetes or idiopathic causes.

Clinical trials, including one randomized trial and several nonrandomized studies, have shown that this device can significantly improve symptoms in patients who do not respond to traditional dietary and drug therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enterra Therapy: gastric neurostimulator for gastroparesis. Gonzalez, HC., Velanovich, V.[2010]

Enterra Therapy, which involves electrical stimulation of the stomach, was evaluated in a study of 25 patients with drug-refractory gastroparesis, showing significant improvements in gastrointestinal symptoms and mental health after 6 months.

Eighteen patients reported better quality of life and symptom relief, contributing to the growing evidence for Enterra Therapy's effectiveness, which may support its potential FDA approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of gastric neurostimulation in patients with gastroparesis. Ross, J., Masrur, M., Gonzalez-Heredia, R., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4208911/

Effectiveness of Gastric Neurostimulation in Patients With ... By showing that Enterra Therapy reduces symptoms of gastroparesis and improves patient quality of life, this study contributes to the increasing amount of data ...

2. enterramedical.com enterramedical.com/hcp/clinical-studies/washington-university-5-year-data/

Washington University 5-year Data Patients with gastroparesis treated with Enterra Therapy showed statisticaly significant improvements in GCSI Total Score and Nausea-Vomiting Subscores at both ...

3. enterramedical.com enterramedical.com/enterra-therapy/

Enterra Therapy The Enterra System is the first and only device specifically designed to relieve the nausea and vomiting associated with gastroparesis from diabetes or unknown ...

4. fda.gov fda.gov/media/181644/download

H990014 - Enterra® Therapy System It includes data from the manufacturer's annual report, post-market medical device reports (MDR) of adverse events and peer-reviewed literature.

5. medtronic.com medtronic.com/in-en/patients/treatments-therapies/neurostimulator-gastroparesis/enterra-2-neurostimulator.html

Enterra II Neurostimulator A programmable, implanted device that generates mild electrical pulses to treat chronic, intractable (resistant to medication) nausea and vomiting associated ...

6. medtronic.com medtronic.com/in-en/patients/treatments-therapies/neurostimulator-gastroparesis/important-safety-information.html

Important Safety Information ENTERRA THERAPY Medtronic Enterra™ Therapy for Gastroparesis: Patient should always discuss the potential risks and benefits of the device with the physician. Indications for ...

7. fda.gov fda.gov/media/107304/download

Executive Summary -Enterra® Therapy System - H990014 This document summarizes the safety data the FDA reviewed in the year following our 2015 report to the PAC. It includes data from the manufacturer's annual ...

8. medtronic.com medtronic.com/uk-en/patients/treatments-therapies/neurostimulator-gastroparesis/important-safety-information.html

Important Safety Information from Medtronic on Enterra ... Authorised for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology ...