Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-24 @ 10:22 PM
Study NCT ID:
NCT05732558
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2023-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'all sensitive data regarding enrolled patients will be transmitted to the Outcomes Assessor anonymously (code assigned to the patient)'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2023-01-16', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure time', 'timeFrame': 'During bone biopsy procedure (after the bone sample has been collected)', 'description': 'Change in the total duration of the procedure (calculated from the time of local anesthesia injection to the time of bone sample collection)'}, {'measure': 'Total number of CT-SCAN', 'timeFrame': 'During bone biopsy procedure (after the bone sample has been collected)', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'endosight accuracy', 'timeFrame': 'During bone biopsy procedure (after the bone sample has been collected)', 'description': 'Distance between the tip of the needle and the center of the target (from 0mm to 10mm)'}, {'measure': 'Total radiation dose', 'timeFrame': 'During bone biopsy procedure (after the bone sample has been collected)', 'description': '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)'}, {'measure': 'Operator satisfaction', 'timeFrame': 'During bone biopsy procedure (after the bone sample has been collected)', 'description': 'satisfaction level of the operator (from 0 to 5 - 1: poor satisfaction, 5: high satisfaction)'}, {'measure': 'Side effects', 'timeFrame': 'During bone biopsy procedure (after the bone sample has been collected)', 'description': 'Total number of major+minor side effects, reported during the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Lesion', 'Bone Tumor', 'Bone Infection']}, 'referencesModule': {'references': [{'pmid': '37468652', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'In this study results obtained in the prospective group will be compared with those obtained in the retrospective group.\n\nTotal N° of patients: 16\n\nPROSPECTIVE GROUP (treated WITH the guidance of endosight):\n\nN° of patients: 8\n\nRETROSPECTIVE GROUP (treated WITHOUT the guidance of endosight):\n\nN° of patients: 8\n\nMain objective of the study:\n\nReduction of execution times by at least 10 minutes; Reduction of the number of CT scans by at least 2 scans.\n\nN°of hospitals involved: 2.\n\nDuration: maximum 6 months from the date of the first enrollment.\n\nNo follow-up is expected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a bone lesion for which a percutaneous biopsy is indicated;\n* Informed consent signed by the patient for participation in the study.\n\nExclusion Criteria:\n\n* Age \\< 18 years;\n* Pregnant and lactating women (assessed through auto declaration of the patient)'}, 'identificationModule': {'nctId': 'NCT05732558', 'briefTitle': 'Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'R.A.W. - S.R.L.'}, 'officialTitle': 'Assessment of Operative Time, Precision, and Safety of an Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy', 'orgStudyIdInfo': {'id': 'ESBB1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prospective', 'description': '8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system', 'interventionNames': ['Procedure: 8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system']}, {'type': 'NO_INTERVENTION', 'label': 'retrospective', 'description': '8 Patients with a bone lesion for which a percutaneous biopsy has been performed from January 2011 to May 2022'}], 'interventions': [{'name': '8 Patients who were prescribed a CT-guided percutaneous bone biopsy, performed with the aid of endosight navigation system', 'type': 'PROCEDURE', 'otherNames': ['augmented reality', 'endosight', 'Bone biopsy', 'Bone tumor', 'Bone Lesion'], 'description': '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.', 'armGroupLabels': ['prospective']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20157', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': "IRCCS Ospedale Galeazzi - Sant'Ambrogio", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R.A.W. - S.R.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}