Hydrogel Embolization for Arterial Bleeding
Recruiting at 17 trial locations
CO
GL
RM
NR
Overseen ByNicole Rissman
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Instylla, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is the Embrace Hydrogel Embolic System safe for use in humans?
How is the Embrace Hydrogel Embolic System treatment different from other treatments for arterial bleeding?
The Embrace Hydrogel Embolic System is unique because it uses a water-based liquid that solidifies into a hydrogel to block blood vessels, which can be more effective and safer than traditional methods like microspheres. This system is designed to fill the blood vessel area and solidify, potentially offering better control and reduced risk of migration compared to other embolic agents.23456
Research Team
SG
Suvranu Ganguli
Principal Investigator
Boston Medical Center
Eligibility Criteria
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.Inclusion Criteria
I am eligible for a procedure to stop bleeding in my body using a catheter.
Exclusion Criteria
In the Investigator's opinion, due to injury severity the subject is not likely to benefit from angioembolization (e.g., in the presence of significant polytrauma, multiple organ failure or shattered organs), Any contraindication to arteriography or the embolization protocol utilized at treating institution, Pregnant or breast-feeding (women of child-bearing potential must undergo a pregnancy test performed in accordance with local institutional requirements and agree to use contraception for at least six months), Hemorrhagic shock (Class IV-see Appendix 1) at time of treatment, Target vascular territory supplied by the pulmonary artery, coronary artery, or cerebral or cerebellar artery (requiring embolization of these arteries) or the artery to be embolized has connections to these arteries via a collateral pathway, Embolization for treatment of spinal arteries, lower GI bleeds, arteriovenous malformations, embolization of arteriovenous shunts, endoleak management, neurovascular bleeds, penetrating trauma of extremities, Forrest Classification Type III UGI bleeds (see Appendix 2), In the investigator's opinion, patient will require embolization of 4 or more discrete vascular territories/arterial injuries (requires that microcatheter be repositioned to discrete area) based on diagnostic angiography or another suitable imaging study, Known or suspected angio-anatomical conditions that in the Investigator's opinion, would prevent the delivery catheter to gain access to the selected position for safe and intended embolization, Known allergies (based on history) to PEG, ferrous compounds, tert Butyl Hydroperoxide, contrast media or procedural sedatives/anesthetics that is not amenable to pre-medication, Presence of medically relevant localized or systemic infection, The patient has other concurrent conditions or known history that in the opinion of the Investigator would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise patient safety or study objectives (including but not limited to ongoing acute infection, life-threatening concomitant trauma or conditions), If known, enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device.
Life expectancy ≤ 30 days
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo transcatheter embolization using the Embrace Hydrogel Embolic System
Immediate
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Extended Follow-up
Participants are monitored for clinical success and safety endpoints
30 days
Treatment Details
Interventions
- Embrace Hydrogel Embolic System
Trial Overview 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Instylla, Inc.
Lead Sponsor
Trials
2
Recruited
270+
Findings from Research
In a study involving 484 patients, second-generation hydrogel coils demonstrated a safety profile comparable to traditional bare platinum coils, with no significant differences in procedural complications or 14-day mortality rates between the two groups.
Hydrogel coils achieved a significantly higher median packing density (39%) compared to bare platinum coils (31%), suggesting improved effectiveness in aneurysm treatment without compromising safety.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results.Taschner, CA., Chapot, R., Costalat, V., et al.[2021]
The thermo-responsive hydroxybutyl chitosan (HBC) hydrogel shows promising potential as an embolic material for occluding blood vessels, demonstrating rapid gelation and strong adhesion to vessel walls after injection in rat models.
HBC hydrogel is noncytotoxic and exhibits excellent compatibility with red blood cells, promoting coagulation around the hydrogel, which helps prevent its migration and enhances its effectiveness in vascular embolization.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Thermo-responsive hydroxybutyl chitosan hydrogel as artery intervention embolic agent for hemorrhage control.Sun, G., Feng, C., Jiang, C., et al.[2018]
The Embrace Hydrogel Embolic System (HES) demonstrated superior safety and efficacy in embolizing hypervascular tumors compared to 40-μm microspheres in a study involving 24 New Zealand white rabbits, with no instances of nontarget embolization.
HES resulted in significantly less vascular recanalization (0%) compared to microspheres (38%), indicating that HES provides more durable embolization and leads to less viable kidney tissue post-procedure.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A Water-Based Liquid Embolic: Evaluation of its Safety and Efficacy in a Rabbit Kidney Model.Ganguli, S., Lareau, R., Jarrett, T., et al.[2021]
References
GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results. [2021]
Thermo-responsive hydroxybutyl chitosan hydrogel as artery intervention embolic agent for hemorrhage control. [2018]
A Water-Based Liquid Embolic: Evaluation of its Safety and Efficacy in a Rabbit Kidney Model. [2021]
A Pilot First-in-Human Study of Embrace, a Polyethylene Glycol-Based Liquid Embolic Agent, in the Embolization of Malignant and Benign Hypervascular Tumors. [2022]
Follow-up of cerebral aneurysm embolization with hydrogel embolic system: Systematic review and meta-analysis. [2018]
Recent Progress in Advanced Hydrogel-Based Embolic Agents: From Rational Design Strategies to Improved Endovascular Embolization. [2023]
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