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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 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.

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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.

Conditions Studied

Gastroparesis Gastroparesis Nondiabetic Gastroparesis Due to Diabetes Mellitus

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

FieldValue
Enrollment Target 50 participants
Start Date 2024-07-25
Est. Completion 2026-12
Phase NA

Sponsor

Enterra Medical

3 total trials

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What the Registry Record Tells You About NCT06560307

The ClinicalTrials.gov registry entry for NCT06560307 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.

NCT06560307 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.

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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.