Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology

NCT ID: NCT02563444

Last Updated: 2025-12-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by comparing the path indicated by the ultrasound fusion (virtual line) and the path actually obtained on the control CT scan (real line).

Compared with ultrasound guidance alone or CT scan alone, the results are expected to be more accurate, saving time and irradiation (not evaluated here).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tissular Lesion

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diagnostic (Biopsy) or Therapeutic Procedure (Infiltration, Ablation)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultrasound fusion guiding system

Group Type EXPERIMENTAL

Ultrasound fusion guiding system - TUS A-500 (Aplio 500)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound fusion guiding system - TUS A-500 (Aplio 500)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age\>18 years
* male or female
* women of childbearing potential should use effective contraceptive measures and indicate the date of the last menstrual
* Patient requiring the use of computed tomographic guidance to perform a diagnostic (biopsy) or therapeutic procedure (infiltration, ablation) on a mobile organ
* patient signed an informed consent

Exclusion Criteria

* Contraindications to the use of X-rays (pregnancy)
* Patients using vital electronic devices (eg: pacemaker or defibrillator)
* Subject under judicial protection
* Subject under tutorship or curatorship
* Inability to give informed informations (subject in emergency situations, comprehension difficulties of the subject, ...)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Afshin GANGI, MD

Role: PRINCIPAL_INVESTIGATOR

Strasbourg's University Hospitals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nouvel Hôpital Civil

Strasbourg, Alsace, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Bing F, Vappou J, Breton E, Enescu I, Garnon J, Gangi A. Accuracy of a CT-Ultrasound Fusion Imaging Guidance System Used for Hepatic Percutaneous Procedures. J Vasc Interv Radiol. 2019 Jul;30(7):1013-1020. doi: 10.1016/j.jvir.2018.11.034. Epub 2019 Mar 25.

Reference Type RESULT
PMID: 30922795 (View on PubMed)

Garnon J, Koch G, Tsoumakidou G, Caudrelier J, Chari B, Cazzato RL, Gangi A. Ultrasound-Guided Biopsies of Bone Lesions Without Cortical Disruption Using Fusion Imaging and Needle Tracking: Proof of Concept. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1267-1273. doi: 10.1007/s00270-017-1638-9. Epub 2017 Mar 29.

Reference Type RESULT
PMID: 28357575 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-A00413-44

Identifier Type: -

Identifier Source: org_study_id