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Study of Enterra Programming with Nocturnal Cycling in Gastroparetics
NCT05980455 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05980455
The ClinicalTrials.gov registry entry for NCT05980455 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Enterra Medical, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05980455 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Kentucky, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05980455?
The interventions under investigation include: Enterra® Therapy System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05980455?
This trial is sponsored by Enterra Medical, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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