XACT ACE Observational Registry
Purpose
Compile real world data on the use of the XACT ACE Robotic System
Condition
- Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥ 18 years of age 2. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite 3. Subject is willing to sign informed consent for the purposes of data collection
Exclusion Criteria
- No exclusion criteria other than listed in the product Instructions for Use (IFU)
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| All subjects | Subjects undergoing CT-guided, minimally invasive percutaneous procedures in an interventional radiology setting |
|
Recruiting Locations
Burlington, Massachusetts 01805
More Details
- Status
- Recruiting
- Sponsor
- Xact Robotics Ltd.
Detailed Description
The purpose of this observational post-market study is to compile real world data on the use of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures. The objectives are to 1) evaluate the proportion of procedures in which the instrument reached the pre-defined target, based on the physician's determination and CT imaging confirmation, 2) To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the at the end of the instrument insertion, and 3) Incidence of intra- and post-procedural adverse events. Up to 500 patients will be enrolled in this multicenter, nonrandomized, single arm registry.