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Embolization Agent

Hydrogel Embolization for Arterial Bleeding

N/A
Recruiting
Led By Suvranu Ganguli
Research Sponsored by Instylla, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients age ≥ 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 30 days post-index procedure
Awards & highlights

Summary

This trialevaluates a device that helps stop bleeding in peripheral arteries.

Who is the study for?
Adults aged 18+ with arterial bleeding in organs like the kidney, liver, spleen or from spontaneous hematomas. Candidates must have not had prior embolization in the affected area and be willing to follow the study's schedule. Pregnant women, those with hemorrhagic shock, certain artery involvement or severe allergies to trial materials are excluded.
What is being tested?
The HALT study is testing the Embrace Hydrogel Embolic System (HES) for stopping bleeding in peripheral arteries by blocking them off (embolization). It aims to see if this method is safe and works well compared to current treatments.
What are the potential side effects?
Potential side effects may include reactions at the site of embolization such as pain or swelling, allergic reactions to materials used in HES, complications related to blocked blood flow like tissue damage or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following index procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following index procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Success
Primary safety endpoint
Technical Success

Find a Location

Who is running the clinical trial?

Instylla, Inc.Lead Sponsor
1 Previous Clinical Trials
150 Total Patients Enrolled
Suvranu GanguliPrincipal InvestigatorBoston Medical Center

Media Library

Embrace Hydrogel Embolic System (Embolization Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05364502 — N/A
Arterial Bleeding Research Study Groups:
Arterial Bleeding Clinical Trial 2023: Embrace Hydrogel Embolic System Highlights & Side Effects. Trial Name: NCT05364502 — N/A
Embrace Hydrogel Embolic System (Embolization Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364502 — N/A
~5 spots leftby Nov 2024
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