Observational registry for the XACT ACE Robotic System in tumor procedures
Observational Post-Market Study of the XACT ACE Robotic System
This study is testing how well the XACT ACE Robotic System works for targeting tumors during minimally invasive procedures to see if it can improve treatment outcomes for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xact Robotics Ltd. Industry-sponsored |
| Locations | 1 site (Burlington, Massachusetts) |
| Trial ID | NCT04950959 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the use of the XACT ACE Robotic System during CT-guided, minimally invasive percutaneous procedures for tumor treatment. The study will evaluate how often the robotic instrument successfully reaches its target as determined by physicians and confirmed by CT imaging. Additionally, it will assess the accuracy of the system by measuring the distance from the instrument tip to the target at the end of the procedure, as well as track any intra- and post-procedural adverse events. Up to 500 patients will be enrolled in this multicenter, nonrandomized, single-arm registry.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing CT-guided, minimally invasive percutaneous procedures in interventional radiology.
Not a fit: Patients not undergoing CT-guided procedures or those who do not consent to data collection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the precision and safety of minimally invasive procedures for tumor treatment.
How similar studies have performed: Similar studies utilizing robotic systems in minimally invasive procedures have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥ 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: 1\. No exclusion criteria other than listed in the product Instructions for Use (IFU)
Where this trial is running
Burlington, Massachusetts
- Lahey Hospital and Medical Center — Burlington, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Mark Macedo
- Email: mark.macedo@xactrobotics.com
- Phone: 5082076505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.