CompletedNot Applicable

Evaluation of the Safety, Effectiveness & Usability of the XACT Robotic System for Image Guided Percutaneous Procedures

United States, Israel60 participantsStarted 2018-09-04

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary endpoint of the study is to evaluate the clinical accuracy of the XACT system.

Timeframe: End of procedure

Trial details

NCT IDNCT03008603

SponsorXact Robotics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-16

View on ClinicalTrials.gov More CT-guided Minimally Invasive Procedures e.g., Biopsies trials