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NCT05980455 · ClinicalTrials.gov registry record · NA
Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
A NA study of Gastroparesis and Gastroparesis Nondiabetic, sponsored by Enterra Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT05980455: Recruiting NA study of Gastroparesis and Gastroparesis Nondiabetic, sponsored by Enterra Medical.
NCT05980455 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 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05980455, 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
- 2
- Study locations
Study Summary
The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures. Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. 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 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
Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline
Conditions Studied
Interventions
- DEVICE Enterra® Therapy System
Study Locations (2)
Kentucky
- University of Louisville - Louisville
Minnesota
- MNGI Digestive Health, P.A. - Coon Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-07-10 |
| Est. Completion | 2025-12 |
| Phase | NA |
What NCT05980455 shows while recruiting
NCT05980455 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.
NCT05980455 reports a single indexed study location in Kentucky, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05980455 about?
NCT05980455 is a clinical study titled "Study of Enterra Programming with Nocturnal Cycling in Gastroparetics". The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures. Participants in this study with existing Enterra® devices will be randomly assigned to one ...
What is the current status of trial NCT05980455?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2023-07-10. Estimated completion is 2025-12.
What conditions does trial NCT05980455 study?
This clinical trial studies the following conditions: Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus.
What interventions are being tested in trial NCT05980455?
The interventions under investigation include: Enterra® Therapy System (DEVICE).
Who is sponsoring clinical trial NCT05980455?
This trial is sponsored by Enterra Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05980455 being conducted?
This trial has 2 study locations across Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05980455'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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