Vascular Anomaly Pathology and Genomics Biopsy Study

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2022-01-31

Brief Summary

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The purpose of this research is to gather information on the safety and effectiveness of core biopsy of vascular anomalies for clinical pathology and clinical genomics studies.

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Detailed Description

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Vascular anomalies or vascular malformations often are treated with minimally invasive sclerotherapy, embolization or ablation based on clinical and imaging features without acquisition of tissue. Over the last two decades there have been significant advancements in the understanding of the genetic basis for various vascular anomalies/malformations, which may guide use of therapies for individualized treatment.

As such, given the emergence of novel medications for treatment of vascular anomalies/malformations based on genetic information, acquisition of tissue for pathology and genomic characterization will be increasingly important as treatment of vascular anomalies/vascular malformations moves toward individualized medicine approach.

Conditions

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Vascular Malformations Vascular Anomaly Hemangioma Arteriovenous Malformations Venous Malformation Klippel Trenaunay Syndrome Lymphatic Malformation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vascular anomaly/malformation biopsy

Subjects with a vascular anomaly will have a research percutaneous vascular anomaly/malformation biopsy completed at the time of the clinically indicated percutaneous sclerotherapy, embolization and/or ablation.

Group Type EXPERIMENTAL

Percutaneous Vascular Anomaly/Malformation Biopsy

Intervention Type PROCEDURE

US-guided percutaneous vascular anomaly core needle biopsy of up to 10 cores using an 18-gauge co-axial core needle biopsy device at the time of clinically indicated sclerotherapy, embolization or ablation treatment.

Interventions

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Percutaneous Vascular Anomaly/Malformation Biopsy

US-guided percutaneous vascular anomaly core needle biopsy of up to 10 cores using an 18-gauge co-axial core needle biopsy device at the time of clinically indicated sclerotherapy, embolization or ablation treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with a clinical and imaging diagnosis of a vascular anomaly.
* No prior treatment for the vascular anomaly.
* Subjects undergoing clinically indicated sclerotherapy, embolization and/or ablation.
* Male or female with age greater than or equal to 18 years.
* Capacity and willingness to provide a written informed consent..

Exclusion Criteria

* Subjects with prior treatment for their vascular anomaly.
* Uncorrectable coagulopathy.
* Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No