Enterra Therapy System for Gastroparesis

(EXPEDITE Trial)

Recruiting at 5 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

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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.

Research Team

Michael Awad, MD, PhD

Principal Investigator

Washington University School of Medicine

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

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

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

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

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

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

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]

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

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

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

Enterra Therapy: gastric neurostimulator for gastroparesis. [2010]