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

500 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Enterra II Neurostimulator for gastroparesis?

Research shows that the Enterra II Neurostimulator, which provides electrical pulses to the stomach, can help improve symptoms and quality of life for patients with severe gastroparesis by enhancing stomach emptying. Studies have found that it reduces symptoms like nausea, vomiting, and bloating, and decreases hospital admissions for these patients. ^{1 2 3 4 5}

Is the Enterra II Neurostimulator safe for humans?

The Enterra Therapy system, used for treating gastroparesis, has been studied in various trials and is considered safe, with no reported deaths and reduced hospital admissions after its use. It has been approved by the FDA under a Humanitarian Device Exemption, indicating it meets certain safety standards. ^{1 2 3 5 6}

How does the Enterra II Neurostimulator treatment differ from other treatments for gastroparesis?

The Enterra II Neurostimulator is unique because it uses electrical pulses to stimulate the stomach muscles, helping to improve gastric emptying in patients with gastroparesis. Unlike other treatments, it involves an implantable device that provides high-frequency, low-energy electrical stimulation, which is particularly beneficial for those who do not respond to medication. ^{1 2 3 5 7}

What is the purpose of this trial?

Humanitarian Device: Authorized by Federal (U.S.A.) Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Research Team

Sachin Kukreja, MD

Principal Investigator

Methodist Heath System

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Effectiveness of gastric neurostimulation in patients with gastroparesis. [2020]

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

Gastric electrical stimulation improves outcomes of patients with gastroparesis for up to 10 years. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness and feasibility of robotic gastric neurostimulator placement in patients with refractory gastroparesis. [2018]

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

Predictive factors for clinical improvement with Enterra gastric electric stimulation treatment for refractory gastroparesis. [2022]

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

Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. [2022]

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

Enterra Therapy: gastric neurostimulator for gastroparesis. [2010]

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

An endoscopic wireless gastrostimulator (with video). [2023]