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Completed

NCT Number: NCT05732558

Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy

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.

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Key information

Conditions

Bone Lesion Bone Diseases Bone Infection Bone Neoplasms Bone Tumor Musculoskeletal Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Ospedale Galeazzi - Sant'Ambrogio

Milan, MI, 20157, Italy

About this study

In this study results obtained in the prospective group will be compared with those obtained in the retrospective group.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Procedure

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 names: augmented reality, endosight, Bone biopsy, Bone tumor, Bone Lesion

Primary outcomes

  1. Procedure time

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

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

  2. Total number of CT-SCAN

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

    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)

Secondary outcomes

  1. endosight accuracy

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

    Distance between the tip of the needle and the center of the target (from 0mm to 10mm)

  2. Total radiation dose

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

    Change in the total radiant dose received by the patient (calculated by summing the radiation emitted for each CT-Scan performed from the anesthesia-point to the collection-point)

  3. Operator satisfaction

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

    satisfaction level of the operator (from 0 to 5 - 1: poor satisfaction, 5: high satisfaction)

  4. Side effects

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

    Total number of major+minor side effects, reported during the procedure

Sponsors and collaborators

Lead sponsor

R.A.W. - S.R.L.

Industry

Registry information

Official study title

Assessment of Operative Time, Precision, and Safety of an Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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