Study of Enhanced Programming Stimulation with the Enterra® Therapy System

Last updated: November 13, 2024
Sponsor: Enterra Medical, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroparesis

Treatment

Enterra Therapy System

Clinical Study ID

NCT06560307
CLN 001-PR-01218
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 theduration 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 withinone year of patient enrollment in the study. Gastroparesis defined as > 60% retainedat 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

Exclusion Criteria:

  1. Post-surgical gastroparesis (e.g., fundoplication, Billroth I or II) or other activestomach or gastrointestinal diseases disorders which could explain symptoms in theopinion 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 pregnantduring 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 symptomssuch as gallbladder disease, small bowel bacterial overgrowth, IBS, inflammatorybowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction

  7. Patients with significant cardiac or cardiovascular disease, malignancy, or otherconditions

  8. Participation in other clinical studies

  9. Use of narcotics more than three days per week or other drugs that may affectmotility (e.g., Glucagon-like peptide 1 (GLP-1) agonist drug)

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

  11. Greater than 3 days of usage per week with 2 or less occurrences each day ofuse, or

  12. Greater than 3 grams of total usage per week

  13. Previous diagnosis or history of orthostatic intolerance, e.g., POTS,neurocardiogenic syncope, orthostatic hypotension

  14. Subject experiences discomfort during stimulation assessment that cannot betolerated

  15. Subjects with an underlying disease leading to follow-up by MRI outside of currentMR conditional indications

  16. Evidence of a failed response to temporary gastric electrical stimulation

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Enterra Therapy System
Phase:
Study Start date:
July 25, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • University of South Florida

    Tampa, Florida 33620
    United States

    Active - Recruiting

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Foundation for Surgical Innovation

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington 98101
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.