[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06267248":3,"trial-entities:NCT06267248":88,"trial-summary:NCT06267248":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":31,"secondary_outcomes":36,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":51,"locations":54,"central_contacts":64,"overall_officials":65,"references":69,"see_also_links":87},"NCT06267248","T05100","Spine Registration Using 3D-Scanning","Pre-pilot Study of Spine Registration Using 3D Scanning","ENROLLING_BY_INVITATION","2028-11","2025-10","2025-10-06","2026-11","Advanced Scanners Inc.","INDUSTRY",false,"The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.",null,[19],"Spine Surgery",[],"OBSERVATIONAL",[],{"count":24,"type":25},10,"ESTIMATED",[27],{"type":28,"name":29,"description":30},"DEVICE","Optical 3D Scanner","An optical 3D scanner used to register spine anatomy to surgical computer navigation systems.",[32],{"measure":33,"description":34,"timeFrame":35},"Spine Registration","Closely match the Advanced Scanners optical scan of the partially exposed surface of the patient vertebra to the corresponding patient's preoperative MRI and\u002For CT scan, thereby learning the position of the rest of the vertebra. This endpoint includes registration of the relevant preoperative MRI or CT scan portion to the portion scanned by Advanced Scanners.","Throughout the surgical procedure",[37,40],{"measure":38,"description":39,"timeFrame":35},"Vertebral Shift Measurement","Use the intraoperative x-ray (typically O-arm) measurements taken at various times in the procedure to validate the capability of our scanner to determine relative shifts between vertebra as a function of time.",{"measure":41,"description":42,"timeFrame":35},"Determination Of Bony Exposure Requirements","Measure the area of the exposed vertebra of registered adjacent segments. Bone regions will be identified in the scan mesh, segmented from the rest of the scan, and their areas determined directly from that surface region by integrating the area of the relevant mesh faces, in units of square millimeters or square centimeters.","ALL","18 Years","80 Years",true,{"inclusion":48,"exclusion":49,"raw_text":50},[],[],"Inclusion Criteria:\n\n1. Patients that require exposure of posterior bony anatomy for visualization as standard of care.\n2. Patients will have had a CT scan performed prior to the procedure as standard of care, or is expected to have a CT scan intraoperatively as standard of care.\n3. Clinically planned for spine surgery.\n4. Able to provide written informed consent from subject, using IRB approved consent form and agrees to comply with protocol requirements.\n5. Patients who do not speak English will be allowed to participate, with the expectation that the site will provide interpreter services to help with the consent process.\n\nExclusion Criteria:\n\n1. Language problems that would prevent from properly understanding instructions in any language.\n2. Patients less than 18 years of age or older than 80 years of age\n3. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.\n4. Special populations: pregnant women, prisoners.\n5. Minimally invasive spine surgery that does not expose the necessary bone\u002Fs.\n6. Spine surgery without posterior exposure.\n7. Patients considered high risk for anesthesia, as determined by operative surgeon",[52,53],"ADULT","OLDER_ADULT",[55],{"facility":56,"city":57,"state":58,"zip":59,"country":60,"geoPoint":61},"Mass General Bringham, Hale Building for Transformative Medicine","Boston","Massachusetts","02115","United States",{"lat":62,"lon":63},42.35843,-71.05977,[],[66],{"name":67,"affiliation":13,"role":68},"Aaron Bernstein, PhD","STUDY_DIRECTOR",[70,74,76,79,82,85],{"pmid":71,"type":72,"citation":73},"26883549","BACKGROUND","Arlt F, Chalopin C, Muns A, Meixensberger J, Lindner D. Intraoperative 3D contrast-enhanced ultrasound (CEUS): a prospective study of 50 patients with brain tumours. Acta Neurochir (Wien). 2016 Apr;158(4):685-694. doi: 10.1007\u002Fs00701-016-2738-z. Epub 2016 Feb 16.",{"type":72,"citation":75},"Daanen, H. A. M. & Ter Haar, F. B. 3D whole body scanners revisited. Displays 34, 270-275 (2013).",{"pmid":77,"type":72,"citation":78},"26590631","Hameeteman M, Verhulst AC, Vreeken RD, Maal TJ, Ulrich DJ. 3D stereophotogrammetry in upper-extremity lymphedema: An accurate diagnostic method. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):241-7. doi: 10.1016\u002Fj.bjps.2015.10.011. Epub 2015 Oct 22.",{"pmid":80,"type":72,"citation":81},"17046629","Kovacs L, Zimmermann A, Brockmann G, Guhring M, Baurecht H, Papadopulos NA, Schwenzer-Zimmerer K, Sader R, Biemer E, Zeilhofer HF. Three-dimensional recording of the human face with a 3D laser scanner. J Plast Reconstr Aesthet Surg. 2006;59(11):1193-202. doi: 10.1016\u002Fj.bjps.2005.10.025. Epub 2006 Mar 9.",{"pmid":83,"type":72,"citation":84},"16289612","Park HK, Chung JW, Kho HS. Use of hand-held laser scanning in the assessment of craniometry. Forensic Sci Int. 2006 Jul 13;160(2-3):200-6. doi: 10.1016\u002Fj.forsciint.2005.10.007. Epub 2005 Nov 9.",{"type":72,"citation":86},"Zhang, D., Lu, G., Li, W., Zhang, L. & Luo, N. Palmprint Recognition Using 3-D Information. IEEE Transactions on Systems, Man, and Cybernetics, Part C (Applications and Reviews) 39, 505-519 (2009).",[],{"nct_id":4,"conditions":89,"biomarkers":90},[19],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]