Bone LesionNCT05732558
Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
A study testing 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system in people with Bone Lesion and Bone Tumor, run by R.A.W. - S.R.L. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Lesion, Bone Tumor, Bone Infection
- What is being tested?
- 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2022to 8 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a bone lesion for which a percutaneous biopsy is indicated;
- Informed consent signed by the patient for participation in the study.
Who cannot join
- Age < 18 years;
- Pregnant and lactating women (assessed through auto declaration of the patient)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Operative Time, Precision, and Safety of an 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.
Read the detailed description
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.
- Conditions
- Bone Lesion, Bone Tumor, Bone Infection
- Being tested
- 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation systemProcedure or surgery
Also called augmented reality, endosight, Bone biopsy, Bone tumor
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.
| Study group | Role | What they receive |
|---|---|---|
| prospective | Experimental | 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: During bone biopsy procedure (after the bone sample has been collected)
Secondary outcomes (4)
endosight accuracy
Distance between the tip of the needle and the center of the target (from 0mm to 10mm)
Measured: During bone biopsy procedure (after the bone sample has been collected)
Total radiation dose
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)
Measured: During bone biopsy procedure (after the bone sample has been collected)
Operator satisfaction
satisfaction level of the operator (from 0 to 5 - 1: poor satisfaction, 5: high satisfaction)
Measured: During bone biopsy procedure (after the bone sample has been collected)
Side effects
Total number of major+minor side effects, reported during the procedure
Measured: During bone biopsy procedure (after the bone sample has been collected)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start16 Dec 2022
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- R.A.W. - S.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732558
- Sponsor's protocol ID
- ESBB1
- Status last verified
- Mar 2023
- First submitted
- 16 Jan 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37468652
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Operative Time, Precision, and Safety of an Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
- ClinicalTrials.gov ID
- NCT05732558
- Acronym / sponsor ID
- ESBB1
- Conditions
- Bone Lesion, Bone Tumor, Bone Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- R.A.W. - S.R.L.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| prospective | Experimental | Procedure: 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system8 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with a bone lesion for which a percutaneous biopsy is indicated;
- Informed consent signed by the patient for participation in the study.
Key exclusion criteria (2 listed)
- Age < 18 years;
- Pregnant and lactating women (assessed through auto declaration of the patient)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation systemAlso: augmented reality, endosight, Bone biopsy, Bone tumorThe 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. | Procedure or surgery | prospective |
Primary outcome
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)
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)
4 secondary outcomes
endosight accuracy
Time frame: During bone biopsy procedure (after the bone sample has been collected)
Total radiation dose
Time frame: During bone biopsy procedure (after the bone sample has been collected)
Operator satisfaction
Time frame: During bone biopsy procedure (after the bone sample has been collected)
Side effects
Time frame: During bone biopsy procedure (after the bone sample has been collected)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Derived from this study: PubMed 37468652Albano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system in people with Bone Lesion and Bone Tumor, run by R.A.W. - S.R.L. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time (time frame: During bone biopsy procedure (after the bone sample has been collected)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05732558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.