(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

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

Study Overview

• Status: Recruiting
• Conditions: Arterial Bleeding in Solid Organs and Peripheral Arteries
• Intervention / Treatment: Device: Embrace HES including Instylla™ Delivery Kit and Instylla™ Microcatheter

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 Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Operations; Phone Number: 1 781-790-4860; Email: Clinical@Instylla.com
• Study Contact Backup: Name: Rachel McElligott; Email: rachelm@instylla.com

Study Locations

• United States
  • California
    • Long Beach, California, United States, 92708
      • Recruiting
      • Memorial Health Services
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Andrew Picel
  • Indiana
    • Indianapolis, Indiana, United States, 46902
      • Recruiting
      • Indiana University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • UNC School of Medicine
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patients age ≥ 18 years old

2. 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:

   1. Non-variceal Upper Gastrointestinal (UGI) bleeds refractory to endoscopic treatment
   2. End organ/visceral bleeds (kidney, liver and spleen including tumor bleeds)
   3. Spontaneous hematoma (e.g., rectus sheath and psoas muscle hematomas)
   4. 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.
3. Subjects with at least one target vessel ≤6mm and Embrace HES can be delivered to the target vessel(s).
4. Subject is willing to comply with follow-up evaluation schedule.
5. No prior embolization in the target territory prior to study entry
6. The subject or a legally authorized representative has provided informed consent approved by the appropriate local IRB/EC.

Exclusion Criteria:

1. Life expectancy ≤ 30 days
2. 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).
3. Any contraindication to arteriography or the embolization protocol utilized at treating institution.
4. 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).
5. Hemorrhagic shock (Class IV-see Appendix 1) at time of treatment
6. 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.
7. Embolization for treatment of spinal arteries, lower GI bleeds, arteriovenous malformations, embolization of arteriovenous shunts, endoleak management, neurovascular bleeds, penetrating trauma of extremities.
8. Forrest Classification Type III UGI bleeds (see Appendix 2)
9. 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.
10. 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.
11. 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
12. Presence of medically relevant localized or systemic infection
13. 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).
14. If known, enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary safety endpoint	Freedom from major adverse events (MAE)	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.	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.	Immediately following index procedure

Collaborators and Investigators

• Sponsor: Instylla, Inc.
• Investigators: Principal Investigator: Suvranu Ganguli, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: INY-P-21-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes