Enterra Therapy System for Gastroparesis

(EXPEDITE Trial)

Recruiting at 6 trial locations

Overseen By Michael Awad, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Enterra Medical, Inc.

Must not be taking: Narcotics, GLP-1 agonists

Disqualifiers: Post-surgical gastroparesis, Pregnancy, Hepatic injury, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new programming method for the Enterra Therapy System, a medical device, to determine if it reduces gastroparesis symptoms more effectively and quickly. Gastroparesis, a condition where the stomach empties too slowly, causes nausea and vomiting. Participants will have the device implanted and be assigned to one of two groups to test different programming methods. Individuals diagnosed with idiopathic or diabetic gastroparesis who frequently experience nausea and vomiting may be suitable for this trial. Participants will track symptoms daily and answer quality of life questions throughout the study. As an unphased trial, this study provides participants the chance to explore innovative treatment programming that could enhance their quality of life.

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 prior data suggests that the Enterra Therapy System is safe for treating gastroparesis?

Research shows that the Enterra Therapy System is generally well-tolerated by people with gastroparesis. In one study, patients experienced a significant decrease in nausea and vomiting, with 54% showing more than a 50% improvement. Another report found that 87.1% of patients were happy with their symptom improvement one year after receiving the device, and 79.7% remained satisfied after five years.

The FDA-reviewed safety data supports these findings, indicating that the treatment remains safe over time. While some people might experience side effects, the treatment is considered safe overall for most. The device has been used extensively, providing substantial information to support its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Enterra Therapy System is unique because it uses electrical stimulation to help manage gastroparesis, a condition that slows or stops the movement of food from the stomach to the small intestine. Unlike standard treatments like dietary changes, medications, or even surgery, which can be hit-or-miss, this system offers a targeted approach by directly stimulating the stomach muscles to improve gastric emptying. Researchers are excited because the system offers customizable stimulation settings, which can be adjusted over time to better meet individual patient needs, potentially leading to more effective and personalized treatment outcomes.

What evidence suggests that the Enterra Therapy System is effective for gastroparesis?

Research shows that the Enterra Therapy System can greatly help people with gastroparesis, a condition where food moves too slowly or stops moving from the stomach to the small intestine. Studies have found that this treatment reduces symptoms like nausea and vomiting by more than half in 54% of patients. Another study found that patients experienced better overall symptoms and quality of life. In this trial, participants will receive either Control Programming Stimulation or Enhanced Programming Stimulation with the Enterra Therapy System. The therapy uses gentle electrical pulses to help control stomach function. These findings suggest that Enterra Therapy can significantly improve life for those dealing with gastroparesis symptoms. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael Awad, MD, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Enterra Therapy System

Trial Overview 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.

How Is the Trial Designed?

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

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.

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]

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.

NCBI (Pubmed)

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. Hou, Q., Lin, Z., Mayo, MS., et al.[2012]

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]

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]

Citations

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

Effectiveness of Gastric Neurostimulation in Patients With ... This study evaluates the effectiveness of Enterra Therapy (Medtronic, Minneapolis, Minnesota) in reducing symptoms and improving the quality of life of patients

2. enterramedical.com enterramedical.com/hcp/clinical-studies/long-term-10-year-outcomes-study4/

Long-term 10-year outcomes study 1 In a retrospective study of 50 patients, Enterra Therapy significantly improved primary endpoint of nausea and vomiting in 54% of patients by greater than 50% ...

3. 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 ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT00157755

Enterra Therapy Clinical Study (Gastric Stimulation for ... This study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11392156/

Clinical Outcomes of a Large, Prospective Series of Gastric ... Patients' overall satisfaction with gastroparesis symptom improvement was high: 87.1% of patients at 1 year and 79.7% at 5 years postoperatively were “satisfied ...