NCT05364502

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Instylla, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Arterial Bleeding in Solid Organs and Peripheral Arteries

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-12-12
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2022-05-06
• Last updated: 2025-11-13

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated device study