U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures

Официальное название

Evaluation of the Epione Robotic System for Image-guided Percutaneous MSK Procedures of the Pelvis and Spine in USA. A Prospective Study on Feasibility, Safety and Accuracy

Обзор

The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults. The main question is the determination of the rate of feasible procedures assisted by the Epione device Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be: * The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate * Additional CT or CBCT scans during the procedure.

Вмешательства

• Устройство Percutaneous procedure in the MSK structures of the pelvis and/or the spine
  The introducer placement is performed with the Epione device.

Первичные конечные точки

• Feasability [Срок оценки: 5 months]

Вторичные конечные точки (2)

• Safety Adverse Event [Срок оценки: 6 months]
• Accuracy [Срок оценки: 5 months]

Критерии участия

Критерии включения

• Patients ≥22 years old,
• Patients approved for CT- or CBCT-guided MSK procedure in the pelvis or spine (except the cervical area) under general anesthesia,
• Patients who have signed an IRB-approved informed consent form
• Patients approved for coverage by their insurance for routine costs involved in this standard of care procedure
• Inclusion criteria linked to the freehand procedure have been discussed and validated

Критерии исключения

• Patients with contraindication to undergo general anesthesia,
• Patients unable to maintain appropriate breathing control,
• Patients requiring CT- or CBCT-guided percutaneous procedure on target areas other than those indicated
• Patients unable to fully understand all relevant aspects of the clinical study necessary for their decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response,
• Pregnant or breast-feeding women,
• Patients subject to a legal protection measure,
• Patients already participating in another conflicting interventional clinical study,
• Patients for whom the scan field of view cannot contain the anatomy of interest, the overlaying skin surface, skin markers and the whole patient reference.
• Patients having a coagulation abnormalities or bleeding disorder
• Patients having an active infection on the day of intervention
• Patients having a history of previous surgery resulting in an existing hardware precluding percutaneous approach
• Exclusion criteria linked to the freehand procedure have been discussed and validated

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 3 центра

• UC San Diego — San Diego
• Baptist Hospital Of Miami, Inc — Miami
• Rush University Medical Center — Chicago

Идентификаторы

NCT: NCT07325578 · CA-BO-CIP-0130

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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