Study of Enhanced Programming Stimulation with the Enterra® Therapy System (EXPEDITE)

November 13, 2024 updated by: Enterra Medical, Inc.

Examination of Programming with the Enterra® Therapy System in a Double-Blinded, Randomized, Prospective Study in the Treatment of Nausea and Vomiting Symptoms Using Gastric Electrical Stimulation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida
        • Contact:
        • Contact:
          • Joseph Sujka, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Contact:
          • Amy Perdue
        • Contact:
          • Abigail Stocker, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
        • Contact:
          • Kellie McFarlin, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
          • Asima Badic
        • Contact:
          • Michael Awad, MD, PhD
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Foundation for Surgical Innovation
        • Contact:
          • Angi Gill
        • Contact:
          • Christy Dunst, MD
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Benaroya Research Institute at Virginia Mason
        • Contact:
          • Cheryl Shaw
        • Contact:
          • Pierre Blais, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Completed informed consent process with signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation
  4. Diagnosed with idiopathic or diabetic gastroparesis
  5. Delayed solid-phase gastric emptying study (Eggbeaters™ test meal), completed within one year of patient enrollment in the study. Gastroparesis defined as > 60% retained at 2 hours and/or >10% retained at 4 hours
  6. Investigator confirms normal endoscopy within one year of enrollment in the study
  7. GCSI-DD score for nausea severity during the qualifying Baseline Period averaging 2.5 or more per week and vomiting averaging 5 or more episodes per week

Exclusion Criteria:

  1. Post-surgical gastroparesis (e.g., fundoplication, Billroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator
  2. History of pyloroplasty or pyloromyotomy or G-POEM
  3. Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study
  4. Active H. pylori infection
  5. Significant hepatic injury (elevated ALT, AST, bilirubin)
  6. Metabolic, mechanical, or mucosal inflammatory causes that may explain GI symptoms such as gallbladder disease, small bowel bacterial overgrowth, IBS, inflammatory bowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction
  7. Patients with significant cardiac or cardiovascular disease, malignancy, or other conditions
  8. Participation in other clinical studies
  9. Use of narcotics more than three days per week or other drugs that may affect motility (e.g., Glucagon-like peptide 1 (GLP-1) agonist drug)

  10. Cannabis and/or cannabinoid use that exceeds either:

    1. Greater than 3 days of usage per week with 2 or less occurrences each day of use, or
    2. Greater than 3 grams of total usage per week
  11. Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension
  12. Subject experiences discomfort during stimulation assessment that cannot be tolerated
  13. Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications
  14. Evidence of a failed response to temporary gastric electrical stimulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Programming Stimulation
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.
Device: Enterra Therapy System
The Enterra® Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.
Other Names:
  • Gastric electrical stimulation
Experimental: Enhanced Programming Stimulation
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.
Device: Enterra Therapy System
The Enterra® Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.
Other Names:
  • Gastric electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vomiting Absolute Frequency
Time Frame: 3 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency
3 Months
Change in Nausea Severity Score
Time Frame: 3 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vomiting Absolute Frequency
Time Frame: 6 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency
6 Months
Change in Nausea Severity Score
Time Frame: 6 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score
6 Months
Change in Total Symptom Score
Time Frame: 3 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score
3 Months
Change in Total Symptom Score
Time Frame: 6 Months
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) total symptom score
6 Months
Change in Quality of Life Score
Time Frame: 3 Months
As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score
3 Months
Change in Quality of Life Score
Time Frame: 6 Months
As measured by the Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QoL) score
6 Months
Change in Vomiting Absolute Frequency
Time Frame: 1 Month
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency
1 Month
Change in Nausea Severity Score
Time Frame: 1 Month
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enterra Medical, Inc.

Investigators

  • Principal Investigator: Michael Awad, MD, PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN 001-PR-01218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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