Arterial Bleeding in Solid Organs and Peripheral ArteriesNCT05364502
(HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial Bleeds
A study testing Embrace HES including Instylla™ Delivery Kit and Instylla™ Microcatheter in people with Arterial Bleeding in Solid Organs and Peripheral Arteries, run by Instylla, Inc. at 22 sites in United States.
Trial summary
To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Bleeding in Solid Organs and Peripheral Arteries
- What is being tested?
- Embrace HES including Instylla™ Delivery Kit and Instylla™ Microcatheter
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 22 sitesUnited States
- Study dates
- 12 Dec 2022to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients age ≥ 18 years old
- Subjects who are candidates for transarterial catheter embolization with arterial bleeding documented on a suitable radiologic imaging and/or endoscopic visualization study taken during the index hospitalization that allows for the source of the arterial injury/bleeding to be localized. Includes (but not limited to) the following:
- Non-variceal Upper Gastrointestinal (UGI) bleeds refractory to endoscopic treatment
- End organ/visceral bleeds (kidney, liver and spleen including tumor bleeds)
- Spontaneous hematoma (e.g., rectus sheath and psoas muscle hematomas)
- Other peripheral arterial bleeds (e.g., pelvic hemorrhage) if not associated with risk of ischemia distal to the lesion or embolization of non-expendable arteries.
Show all 10Show fewer
- Subjects with at least one target vessel ≤6mm and Embrace HES can be delivered to the target vessel(s).
- Subject is willing to comply with follow-up evaluation schedule.
- No prior embolization in the target territory prior to study entry
- The subject or a legally authorized representative has provided informed consent approved by the appropriate local IRB/EC.
Who cannot join
- Life expectancy ≤ 30 days
- 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.
Show all 15Show fewer
- 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).
- Presence of Uncorrectable Coagulopathy: Defined as thrombocytopenia with platelet counts < 40,000/mm3 and/or INR > 2.0.
- If known, enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Maryland
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
UNC School of Medicine
Chapel Hill, North Carolina, 27599
University of Cincinnati
Cincinnati, Ohio, 45267
Nuvance Health
Danbury, Connecticut, 06810
Northwestern
Evanston, Illinois, 60611
Prisma Health
Greenville, South Carolina, 29605
Indiana University
Indianapolis, Indiana, 46902
Memorial Health Services
Long Beach, California, 92708
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Yale University
New Haven, Connecticut, 06520
Mount Sinai Hospital
New York, New York, 10029
Columbia University Milstein
New York, New York, 10032
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner Health
Phoenix, Arizona, 85006
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Stanford University
Stanford, California, 94305
UCLA Harbor Lindquist Institute
Torrance, California, 90502
Medstar Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: 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
To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds.
Read the 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
- Being tested
- Embrace HES including Instylla™ Delivery Kit and Instylla™ Microcatheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embrace HES including Instylla™ Delivery Kit and Instylla™ MicrocatheterDevice
The Embrace Hydrogel Embolic System (HES) is indicated for embolization of peripheral arterial bleeds in vessels ≤6mm
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint
Freedom from major adverse events (MAE)
Measured: Through 30 days post-index procedure
Clinical Success
Defined as the absence of bleeding from the target lesion after embolization with Embrace HES without the need for subsequent embolic devices in the index procedure, emergency surgery, re-embolization or other target vessel re-interventions due to rebleeding.
Measured: Within 30 days of the index procedure
Technical Success
Defined as occlusion of the target vessel or exclusion of the area of arterial damage and/or the cessation of extravasation on angiography after embolization with Embrace HES.
Measured: Immediately following index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start12 Dec 2022
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Bleeding in Solid Organs and Peripheral ArteriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instylla, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suvranu Ganguli, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364502
- Sponsor's protocol ID
- INY-P-21-002
- Status last verified
- Jul 2025
- First submitted
- 3 May 2022
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05364502
- Acronym / sponsor ID
- INY-P-21-002
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Instylla, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients age ≥ 18 years old
- Subjects who are candidates for transarterial catheter embolization with arterial bleeding documented on a suitable radiologic imaging and/or endoscopic visualization study taken during the index hospitalization that allows for the source of the arterial injury/bleeding to be localized. Includes (but not limited to) the following:
- Subjects with at least one target vessel ≤6mm and Embrace HES can be delivered to the target vessel(s).
- Subject is willing to comply with follow-up evaluation schedule.
- No prior embolization in the target territory prior to study entry
Key exclusion criteria (15 listed)
- Life expectancy ≤ 30 days
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embrace HES including Instylla™ Delivery Kit and Instylla™ MicrocatheterThe Embrace Hydrogel Embolic System (HES) is indicated for embolization of peripheral arterial bleeds in vessels ≤6mm | Device | – |
Primary outcome
Primary safety endpoint
Time frame: Through 30 days post-index procedure
Freedom from major adverse events (MAE)
Clinical Success
Time frame: Within 30 days of the index procedure
Defined as the absence of bleeding from the target lesion after embolization with Embrace HES without the need for subsequent embolic devices in the index procedure, emergency surgery, re-embolization or other target vessel re-interventions due to rebleeding.
Technical Success
Time frame: Immediately following index procedure
Defined as occlusion of the target vessel or exclusion of the area of arterial damage and/or the cessation of extravasation on angiography after embolization with Embrace HES.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suvranu Ganguli principal investigator
Boston Medical Center
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embrace HES including Instylla™ Delivery Kit and Instylla™ Microcatheter in people with Arterial Bleeding in Solid Organs and Peripheral Arteries, run by Instylla, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint (time frame: Through 30 days post-index procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.