Study of Enhanced Programming Stimulation with the Enterra® Therapy System for Gastroparesis

This study is looking at whether a new way of programming the Enterra® Therapy System can better help people with gastroparesis (a condition where your stomach empties too slowly). The Enterra® Therapy System is a device that uses mild electrical pulses to help with severe nausea and vomiting. Researchers want to see if this enhanced programming improves symptoms faster and boosts your quality of life. You could join if you are 18 to 70 years old and have been diagnosed with gastroparesis. The study will measure success by looking at how often you vomit and how severe your nausea is after three months. The current status of this study is unclear, so it's not known if they are actively enrolling participants.

Study design
This is an interventional study planning to enroll 50 participants. Participants will be randomly assigned to one of two programming strategies after receiving the Enterra® Therapy System implant.
What's involved
You will answer daily questions about your symptoms using a phone/tablet app and complete quality of life questionnaires at monthly study visits. Your involvement will last up to six months after treatment assignment.
Compensation
Not stated in the trial record.
Follow-up
Your vomiting frequency and nausea severity will be measured at 3 months, and you will be involved in the study for up to six months after treatment assignment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06560307

Study of Enhanced Programming Stimulation with the Enterra® Therapy System

Recruiting
NAAges 18–70InterventionalTreatment
Enterra Medical, Inc.
~50 participants
Updated 2024-11-15 on ClinicalTrials.gov
What's tested:Enterra Therapy System

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Vomiting Absolute Frequency
Measured over 3 Months
+1 more outcome measured
Gastroparesis
Gastroparesis Nondiabetic
Gastroparesis Due to Diabetes Mellitus
6 sites across 6 states
Florida1
Kentucky1
Michigan1
Missouri1
Oregon1
Washington1
  • Michael Awad, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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  • Change in Vomiting Absolute Frequency3 Months

    As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency

  • Change in Nausea Severity Score3 Months

    As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) nausea severity score