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NCT06560307 · ClinicalTrials.gov registry record · NA
Study of Enhanced Programming Stimulation with the Enterra® Therapy System
A NA study of Gastroparesis and Gastroparesis Nondiabetic, sponsored by Enterra Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 6
- Study locations
NCT06560307: Recruiting NA study of Gastroparesis and Gastroparesis Nondiabetic, sponsored by Enterra Medical.
NCT06560307 is a NA study of Gastroparesis and Gastroparesis Nondiabetic that is actively recruiting participants, run by Enterra Medical. The registered enrollment target is 50 participants, below the 301-participant average among 44 other Gastroparesis trials with a reported enrollment target (83% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06560307, a NA study of Gastroparesis and Gastroparesis Nondiabetic, is actively recruiting participants, sponsored by Enterra Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
As measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) weekly vomiting absolute frequency
Conditions Studied
Interventions
- DEVICE Enterra Therapy System
Study Locations (6)
Florida
- University of South Florida - Tampa
Kentucky
- University of Louisville - Louisville
Michigan
- Henry Ford Health System - Detroit
Missouri
- Washington University - St Louis
Oregon
- Foundation for Surgical Innovation - Portland
Washington
- Benaroya Research Institute at Virginia Mason - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-07-25 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT06560307 shows while recruiting
NCT06560307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 301-participant average among 44 other Gastroparesis trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Gastroparesis appearing as the primary indexed condition, and to 1 intervention - of which Enterra Therapy System is the first listed.
NCT06560307 lists 6 locations in 6 states (Florida, Kentucky, Michigan).
Frequently Asked Questions
What is clinical trial NCT06560307 about?
NCT06560307 is a clinical study titled "Study of Enhanced Programming Stimulation with the Enterra® Therapy System". 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 c...
What is the current status of trial NCT06560307?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-07-25. Estimated completion is 2026-12.
What conditions does trial NCT06560307 study?
This clinical trial studies the following conditions: Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus.
What interventions are being tested in trial NCT06560307?
The interventions under investigation include: Enterra Therapy System (DEVICE).
Who is sponsoring clinical trial NCT06560307?
This trial is sponsored by Enterra Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06560307 being conducted?
This trial has 6 study locations across Florida, Kentucky, Michigan, Missouri, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06560307's enrollment target sits among peer trials
50 24th of 44 higher than 20 of 44 other Gastroparesis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroparesis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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