Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
NCT ID: NCT05732558
Last Updated: 2023-03-09
Study Results
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.
COMPLETED
NA
16 participants
INTERVENTIONAL
2022-12-16
2023-03-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bone UltraSonic Scanner (BUSS) Clinical Optimization Study
NCT01056432
Safety & Accuracy Study of the ActiSight Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy
NCT00819533
Incisional Biopsy Versus Core-needle Biopsy in Bone Tumors Analysis
NCT07113301
Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Giant Cell Tumor of Bone Surgery
NCT07315828
Safety & Accuracy of the ActiSight Needle Guidance System in Percutaneous Chest Aspiration and Biopsy
NCT00814450
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Total N° of patients: 16
PROSPECTIVE GROUP (treated WITH the guidance of endosight):
N° of patients: 8
RETROSPECTIVE GROUP (treated WITHOUT the guidance of endosight):
N° of patients: 8
Main objective of the study:
Reduction of execution times by at least 10 minutes; Reduction of the number of CT scans by at least 2 scans.
N°of hospitals involved: 2.
Duration: maximum 6 months from the date of the first enrollment.
No follow-up is expected.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
prospective
8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system
8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system
The study is based on a comparison of the number of CT scans required for needle placement in bone biopsies (trunk area) performed with augmented reality navigation system (endosight) and without.
retrospective
8 Patients with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system
The study is based on a comparison of the number of CT scans required for needle placement in bone biopsies (trunk area) performed with augmented reality navigation system (endosight) and without.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent signed by the patient for participation in the study.
Exclusion Criteria
* Pregnant and lactating women (assessed through auto declaration of the patient)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
R.A.W. - S.R.L.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS Ospedale Galeazzi - Sant'Ambrogio
Milan, MI, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Albano D, Messina C, Gitto S, Chianca V, Sconfienza LM. Bone biopsies guided by augmented reality: a pilot study. Eur Radiol Exp. 2023 Jul 20;7(1):40. doi: 10.1186/s41747-023-00353-w.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ESBB1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.