NCT05732558

Brief Summary

The goal of this clinical study is to evaluate the duration of the procedure, the precision (distance between the needle tip and the centre of the target), and the safety of endosight system in the guidance for bone biopsies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2023

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

January 16, 2023

Last Update Submit

March 8, 2023

Conditions

Bone LesionBone TumorBone Infection

Outcome Measures

Primary Outcomes (2)

  • Procedure time

    Change in the total duration of the procedure (calculated from the time of local anesthesia injection to the time of bone sample collection)

    During bone biopsy procedure (after the bone sample has been collected)

  • Total number of CT-SCAN

    Change in overall number of CT scans performed during the procedure (calculated as the total number of CT scans required to reach the target; from the 1° CT-scan (local anesthesia) to the last CT-scan (sample collection from the bone)

    During bone biopsy procedure (after the bone sample has been collected)

Secondary Outcomes (4)

  • endosight accuracy

    During bone biopsy procedure (after the bone sample has been collected)

  • Total radiation dose

    During bone biopsy procedure (after the bone sample has been collected)

  • Operator satisfaction

    During bone biopsy procedure (after the bone sample has been collected)

  • Side effects

    During bone biopsy procedure (after the bone sample has been collected)

Study Arms (2)

prospective

EXPERIMENTAL

8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system

Procedure: 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system

retrospective

NO INTERVENTION

8 Patients with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022

Interventions

8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation systemPROCEDURE

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.

Also known as: augmented reality, endosight, Bone biopsy, Bone tumor, Bone Lesion
prospective

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with a bone lesion for which a percutaneous biopsy is indicated;
  • Informed consent signed by the patient for participation in the study.

You may not qualify if:

  • Age \< 18 years;
  • Pregnant and lactating women (assessed through auto declaration of the patient)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale Galeazzi - Sant'Ambrogio

Milan, MI, 20157, Italy

Location

Related Publications (1)

  • 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.

    PMID: 37468652DERIVED

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
all sensitive data regarding enrolled patients will be transmitted to the Outcomes Assessor anonymously (code assigned to the patient)
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The study is designed to compare a prospective arm composed of 8 patients who were prescribed a CT-Guided bone biopsy (with the aid of endosight navigation system) with a retrospective arm with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022 (without endosight navigation system)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 17, 2023

Study Start

December 16, 2022

Primary Completion

March 8, 2023

Study Completion

March 8, 2023

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations

IT(1)