TumorsNCT04950959
XACT ACE Observational Registry
An observational study of Tumors, run by Xact Robotics Ltd. at 1 site in United States.
Trial summary
Compile real world data on the use of the XACT ACE Robotic System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects undergoing CT guided, minimally invasive percutaneous procedures in an interventional radiology setting.
Who may be able to join
- ≥ 18 years of age
- Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite
- Subject is willing to sign informed consent for the purposes of data collection
Who cannot join
- 1. No exclusion criteria other than listed in the product Instructions for Use (IFU)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Nanette Matrullo, 781-744-2906, nanette.matrullo@lahey.org
Sebastian Flacke, MD
About this study
Official title: Observational Post-Market Study of the XACT ACE Robotic System
Compile real world data on the use of the XACT ACE Robotic System
Read the 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.
- Conditions
- Tumors
- Being tested
- Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. T
- Keywords
- CT-guided percutaneous procedure, Percutaneous biopsy, XACT ACE Robotic System
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. TDevice
The system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking. The XACT ACE Robotic System uses a computerized quantitative guidance system, which provides real-time, accurate needle guidance, including advancement and steering of the needle from the entry point on the subject's body to the target point within the body.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Subjects undergoing CT-guided, minimally invasive percutaneous procedures in an interventional radiology setting Receives: Device: Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of successful procedures
To evaluate the proportion of procedures in which the instrument reached the pre-defined target based on the physician's determination and CT imaging confirmation.
Measured: 1 hour
System accuracy
To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the end of the instrument insertion.
Measured: 1 hour
Assessment of Safety
Incidence of intra- and post-procedural events
Measured: 2 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Oct 2021
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Xact Robotics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Macedo, Study director, XACT Robotics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950959
- Sponsor's protocol ID
- CLIN-REG-01-2020
- Status last verified
- Oct 2022
- First submitted
- 25 Jun 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Post-Market Study of the XACT ACE Robotic System
- ClinicalTrials.gov ID
- NCT04950959
- Acronym / sponsor ID
- CLIN-REG-01-2020
- Conditions
- Tumors
- Keywords
- CT-guided percutaneous procedure, Percutaneous biopsy, XACT ACE Robotic System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xact Robotics Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compile real world data on the use of the XACT ACE Robotic System
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Device: Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. TSubjects undergoing CT-guided, minimally invasive percutaneous procedures in an interventional radiology setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing CT guided, minimally invasive percutaneous procedures in an interventional radiology setting.
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite
- Subject is willing to sign informed consent for the purposes of data collection
Key exclusion criteria (1 listed)
- 1. No exclusion criteria other than listed in the product Instructions for Use (IFU)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. TThe system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking. The XACT ACE Robotic System uses a computerized quantitative guidance system, which provides real-time, accurate needle guidance, including advancement and steering of the needle from the entry point on the subject's body to the target point within the body. | Device | All subjects |
Primary outcome
Proportion of successful procedures
Time frame: 1 hour
To evaluate the proportion of procedures in which the instrument reached the pre-defined target based on the physician's determination and CT imaging confirmation.
System accuracy
Time frame: 1 hour
To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the end of the instrument insertion.
Assessment of Safety
Time frame: 2 hours post-procedure
Incidence of intra- and post-procedural events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Macedo study director
XACT Robotics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumors, run by Xact Robotics Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Macedo (5082076505, mark.macedo@xactrobotics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of successful procedures (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.