Bone Infection Clinical Trial
Official title:
Assessment of Operative Time, Precision, and Safety of an Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
NCT number | NCT05732558 |
Other study ID # | ESBB1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 16, 2022 |
Est. completion date | March 8, 2023 |
Verified date | March 2023 |
Source | R.A.W. - S.R.L. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | March 8, 2023 |
Est. primary completion date | March 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Ospedale Galeazzi - Sant'Ambrogio | Milano | MI |
Lead Sponsor | Collaborator |
---|---|
R.A.W. - S.R.L. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | endosight accuracy | Distance between the tip of the needle and the center of the target (from 0mm to 10mm) | During bone biopsy procedure (after the bone sample has been collected) | |
Secondary | 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) | During bone biopsy procedure (after the bone sample has been collected) | |
Secondary | Operator satisfaction | satisfaction level of the operator (from 0 to 5 - 1: poor satisfaction, 5: high satisfaction) | During bone biopsy procedure (after the bone sample has been collected) | |
Secondary | Side effects | Total number of major+minor side effects, reported during the procedure | During bone biopsy procedure (after the bone sample has been collected) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04563325 -
Oral-only Antibiotics for Bone and Joint Infections in Children
|
Phase 4 | |
Active, not recruiting |
NCT04945434 -
Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis
|
N/A | |
Active, not recruiting |
NCT02814591 -
Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy
|
||
Recruiting |
NCT03550911 -
Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)
|
||
Not yet recruiting |
NCT04154202 -
The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.
|
N/A | |
Completed |
NCT04440631 -
Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
|
||
Recruiting |
NCT05753215 -
Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection
|
Phase 2 | |
Completed |
NCT03082066 -
Soft Tissue and Bone Diameter in Children and Adults for Intraosseus Access
|
||
Completed |
NCT03403608 -
Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections
|
N/A | |
Completed |
NCT02335905 -
Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT04746001 -
Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection
|
||
Completed |
NCT01677000 -
Clinical Priority Program-Bone Infection Registry
|
||
Completed |
NCT00974493 -
Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)
|
Phase 4 | |
Recruiting |
NCT04538053 -
BonE and Joint Infections - Simplifying Treatment in Children Trial
|
Phase 4 | |
Completed |
NCT03945864 -
Antimicrobial Synthetic Bone Grafts
|
Phase 1/Phase 2 | |
Completed |
NCT03426761 -
Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections
|
Phase 4 | |
Terminated |
NCT03335592 -
Cost of Off-label Antibiotics in Osteoarticular Infections
|
||
Recruiting |
NCT05883995 -
Avis-PHAGEinLYON Clinic
|
||
Not yet recruiting |
NCT06132347 -
Performances of DendrisCHIP®OA in Bone and Joint Infections
|
||
Completed |
NCT05895903 -
Alveolar Ridges Expansion Using Osseodensification Versus Screw Expansion Technique
|
N/A |