Improvement Image Quality for SuperSonic® MACH Ultrasound System

NCT ID: NCT06360926

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-05-23

Brief Summary

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The aim of this Study is to collect radiologist feedback to support the further development and improvement of the imaging modes implemented on the embedded software in the SuperSonic® Ultrasound System (including the probe).

Detailed Description

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Conditions

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Diagnosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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SuperSonic® Ultrasound System equipped with new software iterations used with a new probe

Group Type EXPERIMENTAL

SuperSonic® Ultrasound System

Intervention Type DEVICE

SuperSonic® Ultrasound System equipped with new software iterations used with a new probe and CE marked probes. The new software and probe are the new study investigational device not CE marked

Interventions

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SuperSonic® Ultrasound System

SuperSonic® Ultrasound System equipped with new software iterations used with a new probe and CE marked probes. The new software and probe are the new study investigational device not CE marked

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is ≥ 18 years old and is able to understand and sign the informed consent form.
* Subject is a minor \< 18 years old and the legal representative has signed the informed consent form.
* Subject is scheduled for at least one or more routine ultrasounds.
* Subject is affiliated to National Social Insurance or a Health Insurance Regimen.

Exclusion Criteria

* Subject is unable or unwilling to adhere to Study procedures.
* Subject or his/her legal representative if a minor is unable to express or understand informed consent.
* Subject is under legal protection
* Subject is deprived of liberty by judicial or administrative decision
* Subject undergoes psychiatric treatment under constraint
* Subject is admitted to a health or social establishment for purposes other than research
* Subject has latex allergy.
* Subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SuperSonic Imagine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Necker-Enfants malades

Paris, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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2024-A00526-41

Identifier Type: -

Identifier Source: org_study_id

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