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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 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.

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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.

Conditions Studied

Gastroparesis Gastroparesis Nondiabetic Gastroparesis Due to Diabetes Mellitus

Interventions

  • DEVICE Enterra® Therapy System

Study Locations (2)

Kentucky

  • University of Louisville - Louisville

Minnesota

  • MNGI Digestive Health, P.A. - Coon Rapids

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-07-10
Est. Completion 2025-12
Phase NA

Sponsor

Enterra Medical

3 total trials

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What the Registry Record Tells You About NCT05980455

The ClinicalTrials.gov registry entry for NCT05980455 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 301-participant average among 44 other Gastroparesis trials with a reported enrollment target (83% lower). The listed sponsor is Enterra Medical, which has 3 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.