Peripheral Vascular InterventionsACCESS-PVINCT06141694
Assessment of Clin. Capabilities of LIBERTY® Endovascular Robotic System's Performance & Safety in Periph. Vasc. Interv.
A study testing The LIBERTY® Robotic System in people with Peripheral Vascular Interventions, run by Microbot Medical, INC at 3 sites in United States.
Trial summary
A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions. The study is designed to evaluate the performance and safety of endovascular procedures supported by the LIBERTY® Robotic System. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Peripheral Vascular Interventions
- What is being tested?
- The LIBERTY® Robotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jul 2024to 15 Oct 2024
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is age 22-80 years at screening.
- The subject has been informed of the nature of the study and is willing and able to provide informed consent to participate in the study.
- The subject has a clinical indication for an elective PVI.
- The subject is willing and able to comply with all required study procedures.
- Subject's scheduled procedure is compatible with commercially available peripheral interventional devices that have the following diameter ranges:
- Guidewires: 0.014-0.018"
- Catheters (Microcatheters): 2-3 Fr
- Guide catheter: 4-6 Fr
Who cannot join
- Subject is planned to undergo coronary and/or neuro-interventional procedures during study procedure.
- Subject with vasculature that cannot accommodate the catheter or required accessories according to local routine practice guidelines.
- Subject with contraindication to endovascular approach to the treatment of peripheral vascular disease, similar or same as contraindications in manual procedures.
- Target vessel has been previously treated with any type of a bypass conduit.
- Subject has a contraindication to standard anticoagulation for PVIs.
- Subject has bleeding or a hypercoagulability disorder.
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- Subject has thrombocytopenia (<50 x103 per µL).
- Subject has abnormal, clinically relevant lab results resulting in treatment and/or increased risk to the subject.
- Subject has an elevated serum creatinine (≥2.5 mg/dL or ≥221 mmol/L).
- Subject has an active infection requiring antibiotic or anti-fungal systemic treatment.
- Subject has a known allergy to any material used or any component of the devices used that will be in direct contact with subject's tissue.
- Subject is pregnant or lactating.
- Subject with any medical, social, or psychological conditions which, in the opinion of the investigator, would prohibit appropriate consent or impair completion of the study protocol or study procedures.
- Subject who is incapable, per the investigator's discretion, of following-up with the study visit schedule for any reason.
- Subject is currently participating in an investigational drug or device study or post market registry, or participated in another investigational drug or device study within one month prior to enrollment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Baptist Hospital of Miami
Miami, Florida, 33176
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Assessment of Clinical Capabilities of LIBERTY® Endovascular Robotic System's Performance and Safety in Peripheral Vascular Interventions: A Multi-Center, Single Arm, Prospective Trial (ACCESS-PVI)
A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions. The study is designed to evaluate the performance and safety of endovascular procedures supported by the LIBERTY® Robotic System. The System is configured to deliver and manipulate third-party commercially available surgical devices that are employed in endovascular transcatheter procedures (guidewires, microcatheters, and guiding catheters).
- Conditions
- Peripheral Vascular Interventions
- Being tested
- The LIBERTY® Robotic System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The LIBERTY® Robotic SystemDevice
The LIBERTY® Robotic System is intended for use in the remote delivery and manipulation of guidewires and catheters, and remote manipulation of guide catheters, to facilitate navigation to anatomical targets in the peripheral vasculature.
The LIBERTY® Robotic System is not intended for coronary or neurointerventional procedures.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Robotic Navigation | Experimental | Not described Receives: Device: The LIBERTY® Robotic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness Endpoint
Successful robotic navigation of the guidewire and microcatheter is defined as reaching at least 95% of the predetermined anatomical target locations using the LIBERTY® Robotic System, without switching from a robotic to manual procedure due to difficulty reaching the target site.
Measured: During navigation portion of the procedure.
Secondary outcomes (1)
Safety Endpoint
Safety of the LIBERTY® Robotic System will be evaluated by the number and rate of Adverse Device Effects (ADEs) reported
Measured: Through the three (3) day follow-up visit period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start2 Jul 2024
- Primary completion10 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular InterventionsStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbot Medical, INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141694
- Sponsor's protocol ID
- CLN-001P
- Acronym
- ACCESS-PVI
- Status last verified
- Oct 2024
- First submitted
- 15 Nov 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cornelis FH, Gandhi RT, Rabkin D, Diaz-Cartelle J. In Vivo Evaluation of a Disposable Endovascular Robotic System for Arterial Peripheral Vascular Interventions: A Multicenter Feasibility Study. J Vasc Interv Radiol. 2026 May;37(5):108591. doi: 10.1016/j.jvir.2026.108591. Epub 2026 Feb 13.
PubMed 41692299
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical Capabilities of LIBERTY® Endovascular Robotic System's Performance and Safety in Peripheral Vascular Interventions: A Multi-Center, Single Arm, Prospective Trial (ACCESS-PVI)
- ClinicalTrials.gov ID
- NCT06141694
- Acronym / sponsor ID
- ACCESS-PVI / CLN-001P
- Conditions
- Peripheral Vascular Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Microbot Medical, INCIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 21 Nov 2023 (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.
A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions. The study is designed to evaluate the performance and safety of endovascular procedures supported by the LIBERTY® Robotic System. The System is configured to deliver and manipulate third-party commercially available surgical devices that are employed in endovascular transcatheter procedures (guidewires, microcatheters, and guiding catheters).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Robotic Navigation | Experimental | Device: The LIBERTY® Robotic System |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject is age 22-80 years at screening.
- The subject has been informed of the nature of the study and is willing and able to provide informed consent to participate in the study.
- The subject has a clinical indication for an elective PVI.
- The subject is willing and able to comply with all required study procedures.
- Subject's scheduled procedure is compatible with commercially available peripheral interventional devices that have the following diameter ranges:
Key exclusion criteria (15 listed)
- Subject is planned to undergo coronary and/or neuro-interventional procedures during study procedure.
- Subject with vasculature that cannot accommodate the catheter or required accessories according to local routine practice guidelines.
- Subject with contraindication to endovascular approach to the treatment of peripheral vascular disease, similar or same as contraindications in manual procedures.
- Target vessel has been previously treated with any type of a bypass conduit.
- Subject has a contraindication to standard anticoagulation for PVIs.
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 |
|---|---|---|
| The LIBERTY® Robotic SystemThe LIBERTY® Robotic System is intended for use in the remote delivery and manipulation of guidewires and catheters, and remote manipulation of guide catheters, to facilitate navigation to anatomical targets in the peripheral vasculature. The LIBERTY® Robotic System is not intended for coronary or neurointerventional procedures. | Device | Endovascular Robotic Navigation |
Primary outcome
Effectiveness Endpoint
Time frame: During navigation portion of the procedure.
Successful robotic navigation of the guidewire and microcatheter is defined as reaching at least 95% of the predetermined anatomical target locations using the LIBERTY® Robotic System, without switching from a robotic to manual procedure due to difficulty reaching the target site.
1 secondary outcome
Safety Endpoint
Time frame: Through the three (3) day follow-up visit period.
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 17 Oct 2024.
- Derived from this study: PubMed 41692299Cornelis FH, Gandhi RT, Rabkin D, Diaz-Cartelle J. In Vivo Evaluation of a Disposable Endovascular Robotic System for Arterial Peripheral Vascular Interventions: A Multicenter Feasibility Study. J Vasc Interv Radiol. 2026 May;37(5):108591. doi: 10.1016/j.jvir.2026.108591. Epub 2026 Feb 13.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The LIBERTY® Robotic System in people with Peripheral Vascular Interventions, run by Microbot Medical, INC at 3 sites 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 8 inclusion and 15 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Effectiveness Endpoint (time frame: During navigation portion of the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141694, which also lists 1 linked publication.
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 17 Oct 2024.