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Endovenous Valve Formation System

BlueLeaf® Endovenous Valve Formation System (BlueLeaf System) for Chronic Venous Insufficiency (INFINITE-US Trial)

N/A
Waitlist Available
Research Sponsored by Intervene, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

INFINITE-US Trial Summary

This trial is testing a new treatment for CVI of the lower extremity.

Eligible Conditions
  • Chronic Venous Insufficiency
  • Deep Vein Thrombosis

INFINITE-US Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in revised Venous Clinical Severity Score (rVCSS) from baseline
Primary Safety Endpoint: The number of subjects experiencing a major adverse event (MAE), composed of the following

INFINITE-US Trial Design

1Treatment groups
Experimental Treatment
Group I: InvestigationalExperimental Treatment1 Intervention
Subjects will be treated with the investigational device and followed per protocol.

Find a Location

Who is running the clinical trial?

Intervene, Inc.Lead Sponsor
3 Previous Clinical Trials
17 Total Patients Enrolled

Media Library

BlueLeaf® Endovenous Valve Formation System (Endovenous Valve Formation System) Clinical Trial Eligibility Overview. Trial Name: NCT04225806 — N/A
Chronic Venous Insufficiency Research Study Groups: Investigational
Chronic Venous Insufficiency Clinical Trial 2023: BlueLeaf® Endovenous Valve Formation System Highlights & Side Effects. Trial Name: NCT04225806 — N/A
BlueLeaf® Endovenous Valve Formation System (Endovenous Valve Formation System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04225806 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are offering this experiment?

"A total of five research centres are currently participating in this clinical trial. These include The Vascular Experts located in Darien, the University of North carolina at Chapel Hill and NYU Langone Medical Center both found in New york as well as two additional sites."

Answered by AI

Is enrollment for this experiment currently open?

"Affirmative, the clinicaltrials.gov platform has a record of this medical study that is currently recruiting participants. The trial was originally uploaded on February 13th 2020 and modified most recently in August 11th 2022. 20 people are needed to fill 5 different sites for enrolment in this experiment."

Answered by AI

What is the estimated population of participants in this research trial?

"To fully execute this clinical trial, 20 eligible participants must be recruited. These individuals can join the study at The Vascular Experts in Darien or University of North carolina at Chapel Hill in Chapel Hill."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Allegheny General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System - INFINITE-US
2020. "Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System - INFINITE-US". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04225806.
~3 spots leftby Apr 2025
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