Assessment of Clin. Capabilities of LIBERTY® Endovascular Robotic System's Performance & Safety in Periph. Vasc. Interv.
NCT ID: NCT06141694
Last Updated: 2024-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2024-07-02
2024-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endovascular Robotic Navigation
The LIBERTY® Robotic System
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.
Interventions
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The LIBERTY® Robotic System
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.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. The subject has a clinical indication for an elective PVI.
4. The subject is willing and able to comply with all required study procedures.
5. Subject's scheduled procedure is compatible with commercially available peripheral interventional devices that have the following diameter ranges:
1. Guidewires: 0.014-0.018"
2. Catheters (Microcatheters): 2-3 Fr
3. Guide catheter: 4-6 Fr
Exclusion Criteria
2. Subject with vasculature that cannot accommodate the catheter or required accessories according to local routine practice guidelines.
3. Subject with contraindication to endovascular approach to the treatment of peripheral vascular disease, similar or same as contraindications in manual procedures.
4. Target vessel has been previously treated with any type of a bypass conduit.
5. Subject has a contraindication to standard anticoagulation for PVIs.
6. Subject has bleeding or a hypercoagulability disorder.
7. Subject has thrombocytopenia (\<50 x103 per µL).
8. Subject has abnormal, clinically relevant lab results resulting in treatment and/or increased risk to the subject.
9. Subject has an elevated serum creatinine (≥2.5 mg/dL or ≥221 mmol/L).
10. Subject has an active infection requiring antibiotic or anti-fungal systemic treatment.
11. 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.
12. Subject is pregnant or lactating.
13. 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.
14. Subject who is incapable, per the investigator's discretion, of following-up with the study visit schedule for any reason.
15. 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.
22 Years
80 Years
ALL
No
Sponsors
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Microbot Medical, INC
INDUSTRY
Responsible Party
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Locations
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Baptist Hospital of Miami
Miami, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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CLN-001P
Identifier Type: -
Identifier Source: org_study_id
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