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Procedure

LIBERTY® Robotic System for Peripheral Vascular Interventions (ACCESS-PVI Trial)

N/A
Recruiting
Research Sponsored by Microbot Medical, INC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject is age 22-80 years at screening.
The subject has a clinical indication for an elective PVI.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during navigation portion of the procedure.
Awards & highlights

Summary

This trial aims to test a robotic system called LIBERTY® in people undergoing Peripheral Vascular Interventions. The system helps in performing endovascular procedures using various surgical devices like guidewires

Who is the study for?
This trial is for adults aged 22-80 who need elective Peripheral Vascular Interventions (PVI) and can follow the study procedures. They must be able to use specific sizes of guidewires and catheters, and give informed consent. People not meeting these device compatibility requirements or unable to commit to the study process are excluded.
What is being tested?
The LIBERTY® Robotic System is being tested in this study. It's a single-arm trial assessing how well this system performs in supporting endovascular procedures using third-party surgical devices like guidewires and catheters during PVI.
What are the potential side effects?
While specific side effects aren't listed, typical risks may include complications related to endovascular procedures such as bleeding, infection at the access site, vessel damage, or adverse reactions to contrast materials used during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 22 and 80 years old.
Select...
I am scheduled for a procedure to treat irregular heartbeats.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the three (3) day follow-up visit period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through the three (3) day follow-up visit period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness Endpoint
Secondary outcome measures
Safety Endpoint

Trial Design

1Treatment groups
Experimental Treatment
Group I: Endovascular Robotic NavigationExperimental Treatment1 Intervention

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Who is running the clinical trial?

Microbot Medical, INCLead Sponsor
~0 spots leftby Oct 2024
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