CT-guided Minimally Invasive Procedures e.g., Biopsies Clinical Trial
Official title:
Evaluation of the Safety, Effectiveness & Usability of the XACT Robotic System for Image Guided Percutaneous Procedures
Verified date | September 2021 |
Source | Xact Robotics Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, single-arm study is to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite, e.g., core biopsy, will participate in the summary. Clinical accuracy will be the primary efficacy endpoint. Usability and safety will also be evaluated.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 16, 2021 |
Est. primary completion date | February 16, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men and women over 18 years of age - Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor ablation, etc. - Subject is capable and willing to provide informed consent. - Subject is capable and willing to adhere to the study procedures Exclusion Criteria: - Subjects in whom the target is written 1 cm of a major blood vessel or major nerve. - Subject with lesions in the central and peripheral nervous system and the spine. - Subject with significant coagulopathy - Subjects with a preexisting conditions, which, in the opinion of the investigator, may interfere with the conduct of the study - Subjects with an unstable medical condition, e.g. unstable hypertension, unstable cardiac disease, etc. - Subjects who are uncooperative or cannot follow instructions - Subjects with a mental state that may preclude completion of the study procedure - Female subjects who are pregnant or nursing |
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Center | Jerusalem | |
United States | Lahey Hospital & Medical Center | Burlington | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Xact Robotics Ltd. |
United States, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of Treatment-Emergent Adverse Events | Safety of the XACT device will also be evaluated by reporting the incidence, severity and frequency of all Adverse Events (AE), related and unrelated to the device treatment. | End of procedure | |
Primary | The primary endpoint of the study is to evaluate the clinical accuracy of the XACT system. | Clinical accuracy of the study will be determined by the ability of the XACT system to reach the pre-defined target in each procedure. | End of procedure | |
Secondary | The secondary endpoint of the study is to evaluate the usability of the XACT system under actual use clinical conditions. | usability of the XACT device will be evaluated using a rating scale by assessing the ease of device setup, device operation, pre-operative planning, robot positioning, guiding and needle advancement. | End of procedure |