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

NCT05364502 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-11-13

No results posted yet for this study

Summary

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

Conditions

  • Arterial Bleeding in Solid Organs and Peripheral Arteries

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

Sponsors & Collaborators

  • Instylla, Inc.

    lead INDUSTRY

Principal Investigators

  • Suvranu Ganguli · Boston Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2026-01-31
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05364502 on ClinicalTrials.gov