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ACTIVE NOT RECRUITING
NCT05364502
NA

(HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial Bleeds

Sponsor: Instylla, Inc.

View on ClinicalTrials.gov

Summary

To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds.

Official title: A Prospective Multicenter Single-Arm Staged Study to Evaluate the Safety and Effectiveness of Embrace™ Hydrogel Embolic For Transcatheter Embolization of Arterial Bleeding in Solid Organs and Peripheral Arteries

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2022-12-12

Completion Date

2026-03

Last Updated

2025-11-13

Healthy Volunteers

No

Interventions

DEVICE

Embrace HES including Instylla™ Delivery Kit and Instylla™ Microcatheter

The Embrace Hydrogel Embolic System (HES) is indicated for embolization of peripheral arterial bleeds in vessels ≤6mm

Locations (22)

Banner Health

Phoenix, Arizona, United States

Memorial Health Services

Long Beach, California, United States

Stanford University

Stanford, California, United States

UCLA Harbor Lindquist Institute

Torrance, California, United States

Nuvance Health

Danbury, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Medstar Georgetown University

Washington D.C., District of Columbia, United States

University of Miami

Miami, Florida, United States

Northwestern

Evanston, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Maryland

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Mount Sinai Hospital

New York, New York, United States

Columbia University Milstein

New York, New York, United States

UNC School of Medicine

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Prisma Health

Greenville, South Carolina, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States