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Behavioural Intervention

Enterra Therapy System for Gastroparesis (EXPEDITE Trial)

N/A

Recruiting

Led By Michael Awad, MD, PhD

Research Sponsored by Enterra Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation

Diagnosed with idiopathic or diabetic gastroparesis

Must not have

Significant hepatic injury (elevated ALT, AST, bilirubin)

History of pyloroplasty or pyloromyotomy or G-POEM

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a new programming strategy for the Enterra device can help improve symptoms and quality of life for people with gastroparesis. Participants will have the device implanted, be assigned

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include discomfort at the implant site, potential device-related complications like infection or movement of the device, and any unforeseen reactions from the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I have been diagnosed with gastroparesis due to diabetes or an unknown cause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had surgery on the opening of my stomach.

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I use cannabis more than 3 days a week or more than 3 grams a week.

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I have a history of fainting or feeling dizzy when standing up.

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I use narcotics more than three days a week or take drugs that can affect movement.

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My stomach condition did not improve with temporary electrical stimulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Nausea Severity Score

Change in Quality of Life Score

Change in Total Symptom Score

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced Programming StimulationExperimental Treatment1 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 StimulationActive Control1 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.

0 / 8Eligibility criteria met