CT-guided Minimally Invasive Procedures e.g. BiopsiesNCT04612985
Evaluation of the XACT Robotic System for Image-guided Percutaneous Lung Procedures
A study testing XACT Robotic System in people with CT-guided Minimally Invasive Procedures e.g. Biopsies, run by Xact Robotics Ltd. at 2 sites in 2 countries.
Trial summary
This is a prospective, single arm study, to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite. eg. core, biopsy, will participate in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CT-guided Minimally Invasive Procedures e.g. Biopsies
- What is being tested?
- XACT Robotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2018to Dec 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects in whom the target is written 1 cm of a major blood vessel or major nerve.
- Subject with lesion in the central and peripheral nervous system and the spine.
- Subjects in whom the target is within 1 cm of a major blood vessel or major nerve.
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
About this study
Official title: Evaluation of the Safety, Effectiveness and Usability of the XACT Robotic System for Image Guided Percutaneous Lung Procedures
This is a prospective, single arm study, to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite. eg. core, biopsy, will participate in the study. System and clinical accuracy will be the primary efficacy endpoint. Usability and safety will also be evaluated.
Read the detailed description
This is a prospective, single-arm study is to evaluate the safety, effectiveness and usability of the XACT device. The study will be approved by the Institutional Review Board (IRB) at each of the participating centers prior to patient enrollment.
Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor ablation, etc., and willing to sign an informed consent document will be screened for compliance with the study inclusion and exclusion criteria.
A total of thirty (41) subjects will be enrolled in the study at 5 medical centers. The intention is to recruit subjects, which will cover a variety of CT-guided interventional lung procedures and a variety of different procedural tools that may be used with the device. Investigators will screen patients based on the inclusion/exclusion criteria described below and the subjects' demographic, general medical history, medical condition/indication, coagulation factors, concomitant medications and vital signs will be obtained.
The system accuracy will be the primary efficacy endpoint and is defined as the measured distance from the tip of the needle/tool to the target, once the XACT robot reaches the pre-defined target .
Clinical accuracy will be the secondary efficacy endpoint and is defined as the ability to place the instrument or procedural tool at a location suitable for the planned intervention. The investigator will review the final instrument position on the post-placement CT images to determine if the pre-operative planned target was reached. This information will be used to calculate success rate.
Additionally, the 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. The total time of the procedure will be recorded, as will the number of CT scans performed and the radiation dose (DLP and CTDI).
- Being tested
- XACT Robotic System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XACT Robotic SystemDevice
CT-guided Minimally Invasive Procedures e.g., Biopsies
| Study group | Role | What they receive |
|---|---|---|
| Procedures with XACT Robotic System | Experimental | Device: XACT Robotic System The XACT device is a real-time, CT image guided, 3-dimensional robotic system. The XACT device is intended for use as an image guided positioning and steering system for insertion of clinical tools, such as biopsy needles, ablation needles, etc., during minimally invasive percutaneous lung procedures. The system is defined to guide (i.e., position and steer) the tool according to a predefined trajectory following a registration process between the device's coordinate system and real-time CT images. Receives: Device: XACT Robotic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
System accuracy will be determined by the measured distance from the tip of the needle/tool to the target.
The primary endpoint of the study is to evaluate the system accuracy of the XACT System. System accuracy of the study will be determined by the measured distance from the tip of the needle/tool to the target, once the XACT Robot reaches the pre-defined target.
Measured: At the end of each interventional procedure, approximately 1 hour
Secondary outcomes (1)
Clinical accuracy of the study will be determined by the ability of the XACT system to reach the pre-defined target in each procedure.
The secondary 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.
Measured: At the end of each interventional procedure, approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: The IDE wasn't approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT-guided Minimally Invasive Procedures e.g. BiopsiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xact Robotics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahava Stein, Study director, A. Stein Regulatory Affairs Consulting Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612985
- Sponsor's protocol ID
- CLN-002-00
- Status last verified
- Oct 2020
- First submitted
- 14 Feb 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Effectiveness and Usability of the XACT Robotic System for Image Guided Percutaneous Lung Procedures
- ClinicalTrials.gov ID
- NCT04612985
- Acronym / sponsor ID
- CLN-002-00
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The IDE wasn't approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xact Robotics Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 3 Nov 2020 (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.
This is a prospective, single arm study, to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite. eg. core, biopsy, will participate in the study. System and clinical accuracy will be the primary efficacy endpoint. Usability and safety will also be evaluated.
Detailed description
This is a prospective, single-arm study is to evaluate the safety, effectiveness and usability of the XACT device. The study will be approved by the Institutional Review Board (IRB) at each of the participating centers prior to patient enrollment.
Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor ablation, etc., and willing to sign an informed consent document will be screened for compliance with the study inclusion and exclusion criteria.
A total of thirty (41) subjects will be enrolled in the study at 5 medical centers. The intention is to recruit subjects, which will cover a variety of CT-guided interventional lung procedures and a variety of different procedural tools that may be used with the device. Investigators will screen patients based on the inclusion/exclusion criteria described below and the subjects' demographic, general medical history, medical condition/indication, coagulation factors, concomitant medications and vital signs will be obtained.
The system accuracy will be the primary efficacy endpoint and is defined as the measured distance from the tip of the needle/tool to the target, once the XACT robot reaches the pre-defined target .
Clinical accuracy will be the secondary efficacy endpoint and is defined as the ability to place the instrument or procedural tool at a location suitable for the planned intervention. The investigator will review the final instrument position on the post-placement CT images to determine if the pre-operative planned target was reached. This information will be used to calculate success rate.
Additionally, the 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. The total time of the procedure will be recorded, as will the number of CT scans performed and the radiation dose (DLP and CTDI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedures with XACT Robotic System | Experimental | Device: XACT Robotic SystemDevice: XACT Robotic System The XACT device is a real-time, CT image guided, 3-dimensional robotic system. The XACT device is intended for use as an image guided positioning and steering system for insertion of clinical tools, such as biopsy needles, ablation needles, etc., during minimally invasive percutaneous lung procedures. The system is defined to guide (i.e., position and steer) the tool according to a predefined trajectory following a registration process between the device's coordinate system and real-time CT images. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Subjects in whom the target is written 1 cm of a major blood vessel or major nerve.
- Subject with lesion in the central and peripheral nervous system and the spine.
- Subjects in whom the target is within 1 cm of a major blood vessel or major nerve.
- Subject with significant coagulopathy
- Subjects with a preexisting conditions, which, in the opinion of the investigator, may interfere with the conduct of the study.
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 |
|---|---|---|
| XACT Robotic SystemCT-guided Minimally Invasive Procedures e.g., Biopsies | Device | Procedures with XACT Robotic System |
Primary outcome
System accuracy will be determined by the measured distance from the tip of the needle/tool to the target.
Time frame: At the end of each interventional procedure, approximately 1 hour
The primary endpoint of the study is to evaluate the system accuracy of the XACT System. System accuracy of the study will be determined by the measured distance from the tip of the needle/tool to the target, once the XACT Robot reaches the pre-defined target.
1 secondary outcome
Clinical accuracy of the study will be determined by the ability of the XACT system to reach the pre-defined target in each procedure.
Time frame: At the end of each interventional procedure, approximately 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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.
Ahava Stein study director
A. Stein Regulatory Affairs Consulting Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XACT Robotic System in people with CT-guided Minimally Invasive Procedures e.g. Biopsies, run by Xact Robotics Ltd. at 2 sites in 2 countries.
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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System accuracy will be determined by the measured distance from the tip of the needle/tool to the target. (time frame: At the end of each interventional procedure, approximately 1 hour). 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 3 Nov 2020.