Hydrogel Embolization for Arterial Bleeding

Not currently recruiting at 23 trial locations

Overseen By Nicole Rissman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Instylla, Inc.

Disqualifiers: Pregnancy, Hemorrhagic shock, Polytrauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the Embrace Hydrogel Embolic System, a treatment designed to stop arterial bleeding. The main goal is to determine its safety and effectiveness for individuals with specific types of arterial bleeding, such as stomach bleeds unresponsive to other treatments or bleeds in organs like the kidney or liver. Suitable participants have a confirmed arterial bleed via imaging and have not undergone similar treatments before. The trial aims to assist those facing challenging bleeding issues. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new solutions for managing difficult bleeding conditions.

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.

What prior data suggests that the Embrace Hydrogel Embolic System is safe for transcatheter embolization of peripheral arterial bleeds?

Research shows that the Embrace Hydrogel Embolic System has already received FDA approval for a different use. It blocks blood flow in small arteries supplying certain types of tumors. This approval indicates the system has passed strict safety checks for that specific use.

In earlier studies, patients using the Embrace Hydrogel for this purpose did not report major safety issues, suggesting it is generally safe for blocking blood flow in small arteries.

However, using the Embrace Hydrogel to stop arterial bleeding represents a new application. While past safety data appears promising, this study will help confirm its safety and effectiveness for this new purpose. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Embrace Hydrogel Embolic System is unique because it uses a hydrogel to stop arterial bleeding, offering a different approach from the current standard treatments like metal coils and liquid embolics. Unlike these traditional options, the hydrogel expands upon contact with blood, forming a stable barrier and effectively sealing the bleed. This system promises a more targeted and potentially safer treatment, reducing the risk of complications and improving patient outcomes. Researchers are excited because it could provide a quicker, more efficient solution for managing arterial bleeding.

What evidence suggests that the Embrace Hydrogel Embolic System is effective for arterial bleeding?

Research has shown that the Embrace Hydrogel Embolic System effectively stops bleeding in certain situations. It is approved for blocking blood flow to small, highly vascular tumors in peripheral arteries. This approval followed the device's demonstrated ability to stop blood flow in these areas. In other studies, the system significantly reduced bleeding and improved survival in models with bleeding problems. These findings suggest that the Embrace Hydrogel Embolic System could effectively manage bleeding in peripheral arteries. ^{2 3 4 6 7}

Who Is on the Research Team?

Suvranu Ganguli

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

Who Is Running the Clinical Trial?

Instylla, Inc.

Lead Sponsor

Trials

2

Recruited

270+

Published Research Related to This Trial

The hydrogel embolic system (HES) for treating cerebral aneurysms shows a lower total recurrence rate (17%) compared to bare platinum coils (BPC) (approximately 27%), suggesting it may be a more effective option for preventing aneurysm recurrence.

In a review of 13 studies involving 1683 embolized aneurysms, HES demonstrated a pooled odds ratio of 0.63 for total recurrence compared to BPC, indicating a significant advantage for HES in maintaining aneurysm occlusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up of cerebral aneurysm embolization with hydrogel embolic system: Systematic review and meta-analysis. Serafin, Z., Di Leo, G., Pałys, A., et al.[2018]

The Embrace Hydrogel Embolic System (HES) achieved a 100% technical success rate in embolizing tumors, indicating its efficacy in treating both benign and malignant hypervascular tumors in a study of 8 patients.

The procedure was generally easy to perform, with an average ease of use rating of 3.3 out of 5, and no serious adverse events were linked to the embolic agent, suggesting it is a safe option for tumor embolization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot First-in-Human Study of Embrace, a Polyethylene Glycol-Based Liquid Embolic Agent, in the Embolization of Malignant and Benign Hypervascular Tumors. Goh, GS., Goodwin, MD., Huang, JF., et al.[2022]

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]

Transcatheter arterial embolization is a safe and effective minimally invasive treatment for vascular diseases and tumors, with hydrogel-based embolic agents showing promise in overcoming limitations of traditional agents.

Recent advancements in polymer-based hydrogels include features like in situ gelling, drug delivery capabilities, and smart responsiveness, which could enhance the efficacy and functionality of embolization procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Progress in Advanced Hydrogel-Based Embolic Agents: From Rational Design Strategies to Improved Endovascular Embolization. Li, X., Ullah, MW., Li, B., et al.[2023]

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]

Citations

1. evtoday.com evtoday.com/news/instyllas-embrace-hydrogel-embolic-system-approved-by-fda

Instylla's Embrace Hydrogel Embolic System Approved by ... The device has been approved for the embolization of hypervascular tumors in peripheral arteries ≤ 5 mm. According to the company, Embrace HES ...

2. clinicaltrial.be clinicaltrial.be/en/details/175098?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

(HALT) Embrace Hydrogel Embolic System (HES) Study of ... Defined as the absence of bleeding from the target lesion after embolization with Embrace HES without the need for subsequent embolic ...

3. instylla.com instylla.com/instylla-gains-u-s-fda-premarket-approval-for-embrace-hydrogel-embolic-system/

Instylla Gains U.S. FDA Premarket Approval for Embrace™ ... Embrace HES is indicated to embolize hypervascular tumors in peripheral arteries ≤ 5 mm. Embrace HES consists of two injectable liquid ...

4. evtoday.com evtoday.com/news/instyllas-embrace-hydrogel-embolic-system-evaluated-preclinical-hemorrhage-models

Instylla's Embrace Hydrogel Embolic System Evaluated in ... Under coagulopathic conditions, Embrace HES showed improved survival time and a significant reduction in bleeding compared to the control group, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04523350

Instylla HES Hypervascular Tumor Pivotal Study To determine whether Instylla HES has the ability to effectively embolize targeted arterial segments of hypervascular tumors.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05364502?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Instylla,%20Inc.%22)&viewType=Table&rank=2

(HALT) Embrace Hydrogel Embolic System (HES) Study of ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. mountsinai.org mountsinai.org/clinical-trials/halt-embrace-hydrogel-embolic-system-hes-study-of-embolization-in-peripheral-arterial-bleeds

(HALT) Embrace Hydrogel Embolic System (HES) Study of ... Summary: To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds.