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Bioprosthetic Venous Valve

VenoValve® Implant for Venous Insufficiency

N/A

Recruiting

Research Sponsored by Hancock Jaffe Laboratiores, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failure of at least 3 months of standard care including compression therapy, and in C6 patients, wound care

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12 months and annually thereafter through 5 years

Awards & highlights

Study Summary

This trial is looking at a new valve that can be implanted in people with a specific type of heart valve problem. The aim is to see if it is safe and effective.

Who is the study for?

This trial is for adults over 18 with severe leg vein problems (C4b-C6) who haven't improved after 3 months of standard care. They must be able to have an ultrasound, walk unaided, not be pregnant or breastfeeding, agree to birth control if applicable, and have a BMI under 40. People can't join if they've had recent blood clots, other trials within 30 days, certain vein procedures within six weeks, untreated major vein blockages, specific heart conditions or sensitivities to materials in the device.Check my eligibility

What is being tested?

The study tests the VenoValve®, a bioprosthetic valve surgically placed into deep veins as a treatment for patients whose leg veins don’t close properly causing swelling and ulcers. It's a single-group study where all participants receive the valve to see how safe and effective it is.See study design

What are the potential side effects?

While specific side effects are not listed here, surgical implantation of devices like VenoValve® may cause pain at the surgery site, infection risk from surgery or device itself could lead to inflammation or fever; there might also be risks related to improper function of the implanted valve.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried standard treatments like compression therapy for over 3 months without success.

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I am 18 years old or older.

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I have a negative COVID-19 test taken within the last 6 days or I am fully vaccinated.

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I agree to use birth control from the start to the end of the study.

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I am a woman who can have children and have a recent negative pregnancy test.

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My vein for the procedure is at least 8 mm wide.

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I am not breastfeeding and do not plan to during the study.

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I can attend all follow-up appointments after treatment.

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I have a vein problem due to a clot or other causes.

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I can walk on my own without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12 months and annually thereafter through 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12 months and annually thereafter through 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 months and annually thereafter through 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary safety endpoint is the composite of the following Major Adverse Events

Secondary outcome measures

Major Adverse Event rates

Trial Design

1Treatment groups

Experimental Treatment

Group I: VenoValveExperimental Treatment1 Intervention

Subjects who receive VenoValve implant

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

SyntactxNETWORK

22 Previous Clinical Trials

1,147,364 Total Patients Enrolled

AXIOM Real Time MetricsUNKNOWN

3 Previous Clinical Trials

670 Total Patients Enrolled

Hancock Jaffe Laboratiores, IncLead Sponsor

Media Library

Hancock-Jaffe bioprosthetic venous valve (VenoValve®) (Bioprosthetic Venous Valve) Clinical Trial Eligibility Overview. Trial Name: NCT04943172 — N/A

Deep Vein Thrombosis Research Study Groups: VenoValve

Deep Vein Thrombosis Clinical Trial 2023: Hancock-Jaffe bioprosthetic venous valve (VenoValve®) Highlights & Side Effects. Trial Name: NCT04943172 — N/A

Hancock-Jaffe bioprosthetic venous valve (VenoValve®) (Bioprosthetic Venous Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04943172 — 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 participants are being administered treatment in this trial?

"Affirmative. The clinical trial is currently recruiting for a total of 75 participants across 25 sites, according to the information on clinicialtrials.gov - which was last modified on September 23rd 2022. It was initially posted on August 27th 2021."

Answered by AI

How many medical centers are conducting this investigation?

"Presently, 25 medical clinics are conducting this trial in cities like Bellevue, Pittsburgh and Buffalo. To ensure minimal travel requirements if you decide to participate, it is recommended that you select the clinic closest to your residence."

Answered by AI

Is enrollment for this experiment still accepting participants?

"Indeed, the clinicaltrials.gov portal confirms that this study is actively recruiting participants. The trial was first published on August 27th 2021 and has been recently updated to reflect its need for 75 participants at 25 sites across America."

Answered by AI