Lung DiseasesNCT04651517
Pilot Study of the ACE System in Lung Procedures
A study testing XACT ACE Robotics study arm in people with Lung Diseases, run by Xact Robotics Ltd. at 1 site in United States.
Trial summary
To evaluate the XACT ACE Robotic System in lung procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- XACT ACE Robotics study arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 3 Aug 2021
- 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
- 18 years of age
- 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.
- Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure
- Subject is willing to sign informed consent
- Subject is capable of adhering to study procedures
Who cannot join
- Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart
- Subject with significant coagulopathy
- Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study
- Subjects who are pregnant or nursing
- Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
About this study
Official title: Pilot Study of the XACT Robotics ACE System for Image Guided Percutaneous Procedures in the Lung
To evaluate the XACT ACE Robotic System in lung procedures.
Read the detailed description
The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous lung procedures. 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. This study will evaluate safety and accuracy of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures of the lung in the interventional radiology suite.
- Conditions
- Lung Diseases
- Being tested
- XACT ACE Robotics study arm
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XACT ACE Robotics study armDevice
Subjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Subjects undergoing procedures with the XACT ACE Robotic system. Receives: Device: XACT ACE Robotics study arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence, severity, and frequency of adverse events and device-related adverse events
Measured: 30 days
Secondary outcomes (2)
Secondary Performance Evaluation - Clinical Accuracy
Percent of procedures in which the needle reached the pre-defined target based on the physician's determination and CT imaging confirmation (clinical accuracy)
Measured: 1 hour
Secondary Performance Evaluation - System Accuracy
The measured distance from the tip of the needle/tool to the target location at the end of the needle/tip insertion.
Measured: 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 Dec 2020
- Study start15 Mar 2021
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects 18 years of age or older who are undergoing CT guided, minimally invasive percutaneous procedures of the lung.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xact Robotics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastian Flacke, MD, Principal investigator, Lahey Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651517
- Sponsor's protocol ID
- CLIN-LUNG-01-2020
- Status last verified
- Aug 2021
- First submitted
- 17 Nov 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- 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 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the XACT Robotics ACE System for Image Guided Percutaneous Procedures in the Lung
- ClinicalTrials.gov ID
- NCT04651517
- Acronym / sponsor ID
- CLIN-LUNG-01-2020
- Conditions
- Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Xact Robotics Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 3 Dec 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.
To evaluate the XACT ACE Robotic System in lung procedures.
Detailed description
The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous lung procedures. 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. This study will evaluate safety and accuracy of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures of the lung in the interventional radiology suite.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects 18 years of age or older who are undergoing CT guided, minimally invasive percutaneous procedures of the lung.
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: XACT ACE Robotics study armSubjects undergoing procedures with the XACT ACE Robotic system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age
- 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.
- Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure
- Subject is willing to sign informed consent
- Subject is capable of adhering to study procedures
Key exclusion criteria (5 listed)
- Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart
- Subject with significant coagulopathy
- Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study
- Subjects who are pregnant or nursing
- Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)
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 ACE Robotics study armSubjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System. | Device | Study arm |
Primary outcome
Adverse Events
Time frame: 30 days
Incidence, severity, and frequency of adverse events and device-related adverse events
2 secondary outcomes
Secondary Performance Evaluation - Clinical Accuracy
Time frame: 1 hour
Secondary Performance Evaluation - System Accuracy
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- 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.
Sebastian Flacke, MD principal investigator
Lahey Hospital & Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XACT ACE Robotics study arm in people with Lung Diseases, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (time frame: 30 days). 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 9 Aug 2021.