Safety and Efficacy Of Amber Peripheral Liquid Embolic System (OPAL)

Safety and Efficacy Of Amber Peripheral Liquid Embolic System: a First-in-HumAn & PivotaL Study

A prospective, single-arm, multicenter, open-label, First-in-Human & Pivotal Study to assess the safety and efficacy of amber SEL-P in 70 patients requiring peripheral embolization: vascular anomalies, hemorrhages, aneurysms, and pseudoaneurysms, varicose veins, portal vein, hypervascular tumors, type -II endoleaks, and pathological organs.

The study will be divided into two consecutive stages. Stage I will be dedicated to testing the device's safety, followed immediately by stage II, aimed to test the device's efficacy. The overall study sample will be used to assess the device safety and efficacy in all the enrolled participants.

Study Overview

• Status: Active, not recruiting
• Conditions: Hemorrhage; Varicose Veins; Aneurysm; Vascular Anomalies; Pseudoaneurysm; Portal Vein Embolization; Hypervascular Tumor; Type II Endoleak; Pathological Organ
• Intervention / Treatment: Device: amber SEL-P Peripheral Liquid Embolic System

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Hospital Universitario y Politécnico La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged ≥ 18 and < 95 years presenting with one of the following indications:

  • Varicose vein embolization:

    • Pelvic congestion syndrome (uterine venous engorgement, and/or moderate or severe engorgement of the ovarian plexus, and/or filling of the veins across the midline or filling of vulvar or thigh varicosities, and/or reflux throughout the entire course of the ovarian vein.
    • Varicocele (symptomatic varicocele, and/or infertility or subfertility).
    • Varicose veins in patients with portal hypertension undergoing Transjugular Intrahepatic Portosystemic Shunt (TIPS) that require embolization.
  • Type II endoleak: Persistent type II endoleak and/or an associated sac expansion > 5 mm after 6 months or 10 mm after 12 months.
  • Insufficient liver remnant requiring portal vein embolization (PVE) before liver resection: Predicted insufficient liver remnant after surgery (≤20% in a normal liver, ≤30% in liver with intermediate disease without cirrhosis, and ≤40% in liver with cirrhosis)
  • Active arterial hemorrhage and/or pseudoaneurysm: Uncontrolled massive hemorrhage caused by tumor, trauma or arteriovenous shunt formation (congenital or acquired), and/or up to 3 bleeding sites in the same organ or anatomic region
  • Pathologic organ (i.e. non-functioning transplanted kidney, preoperative hip replacement, hypersplenism conditioning low platelet count; excluding brain)
  • Hypervascular tumors
  • Vascular anomalies

Exclusion Criteria:

• Patients with known hypersensitivity or allergy to amber-20, dimethylsulfoxide (DMSO) solvent, or contrast agent
• Previously failed embolization procedure, except for those treated with coils
• Patient in whom according to the investigator criteria a complete vascular occlusion would not be feasible in a single procedure
• Any condition that exposes the patient to a high risk for complications according to the investigator's criteria (e.g., but not limited to, non-correctable coagulopathy, uncontrolled sepsis, underlying life-threatening condition, etc.)
• Patients participating in another interventional study that has not completed it primary endpoint assessment.
• Pregnant or breastfeeding women.
• Patients unable or unwilling to provide a written informed consent.
• Recurrent varicose vein embolization
• Type II endoleak: with high flow or reflux that cannot be prevented using coils or balloon microcatheter, and high risk of medullar ischemic damage
• Active arterial bleeding and/or pseudo aneurysm with: severe hemodynamical instability (e.g., but not limited to, sustained hypotension [mean arterial pressure < 60 mmHg], tachycardia >120 beats/minute, requirement of high doses of vasopressors, etc.) at the moment of the procedure, and/or hb < 8 g/dL before the procedure, and/or retroperitoneal hemorrhages or hemoptysis, identification of spinal or medullar vessels.
• Central nervous system and central circulatory system vascular anomalies.
• Iodine contrast allergy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: amber SEL-P Treatment; Patients requiring peripheral embolization: vascular anomalies, hemorrhages, aneurysms, and pseudoaneurysms, varicose veins (including varicocele and pelvic congestion syndrome), portal vein, hypervascular tumors, type -II endoleaks, and pathological organs.	Device: amber SEL-P Peripheral Liquid Embolic System; Transcatheter arterial or venous embolization with the liquid embolic agent amber SEL-P embolization across seven different indications for peripheral embolization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-procedure serious adverse events related to amber SEL-P (Stage I)	Rate of peri-procedure serious adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee.	Up to 24 hours after embolization procedure
Rate of complete vascular occlusion (Stage II)	Rate of complete vascular occlusion as defined by angiography at the end of the procedure.	Embolization procedure day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of any peri-procedure adverse events related to amber SEL-P (Stage I)	Rate of any peri-procedure adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee.	Up to 24 hours after embolization procedure
Rate of complete vascular occlusion according clinical indication (Stage II)	Rate of complete vascular occlusion as defined by angiography at the end of the procedure according to clinical indication.; Vascular anomalies (excluding the central nervous system and central circulatory system).; Hemorrhages, aneurysms, and pseudoaneurysms.; Varicose veins (including hemorrhoids, varicocele, and pelvic congestion syndrome).; Portal embolization.; Hypervascular tumors.; Type II endoleaks.; Pathological organs (renal grafts, hypersplenism).	Embolization procedure day
Rate of peri-procedure serious adverse events related to amber SEL-P (Stage II)	Rate of peri-procedure serious adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee.	Up to 24 hours after embolization procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-procedure serious adverse event (Stage I and Stage II)	Rate of peri-procedure serious adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee.	Up to 24 hours after embolization procedure
Technical success (Stage I and Stage II)	Rate of complete vascular occlusion as defined by angiography at the end of the procedure	Embolization procedure day
Peri-procedure adverse events (Stage I and Stage II)	ate of any peri-procedure adverse events related to amber SEL-P (device-related but not related to the procedure) at 24 hours, adjudicated by an independent clinical events committee.	Up to 24 hours after embolization procedure
Technical success per indication (Stage I and Stage II)	Rate of complete vascular occlusion as defined by angiography at the end of the procedure according to clinical indication	Embolization procedure day
Any Serious Adverse Events (Stage I and Stage II)	Total number of any serious adverse events	up to 6 moonths
Any Adverse Events (Stage I and Stage II)	otal number of any adverse events	up to 6 moonths
Survival rate (Stage I and Stage II)	Survival rate	up to 6 moonths
Visual Analog Scale (VAS) injection (Stage I and Stage II)	Visual Analog Scale (VAS) to evaluate the pain at device injection (between 0: no pain to 10: intolerable pain)	Embolization procedure day
Visual Analog Scale (VAS) varicose vein (Stage I and Stage II)	Visual Analog Scale (VAS) to evaluate pain improvement in patients with painful varicose vein embolization	up to 6 moonths
Unanticipated uses of another liquid agent (Stage I and Stage II)	Total number of unanticipated uses of another liquid agent for embolization	Embolization procedure day
Volume of amber SEL-P (Stage I and Stage II)	Mean volume of amber SEL-P used during the index procedure	Embolization procedure day
Vials per patient of amber SEL-P (Stage I and Stage II)	Mean vials per patient of amber SEL-P used during the index procedure	Embolization procedure day
Degree of occlusion (Stage I and Stage II)	Mean degree of occlusion of the target vessel(s).	Embolization procedure day
Re-interventions (Stage I and Stage II)	Total number of re-interventions for the study procedure.	up to 6 moonths
Clinical success	oVaricose vein embolization: absence of reflux on ultrasound Doppler at 1M FU, reduction in macroscopic varicose veins and or improvement of pain at least 2 points measured by means of visual analogue scale (VAS). oType II endoleaks: stability or reduction of the aneurysm's anteroposterior and transverse maximal diameters on a computed tomography (CT) scan at 6 months compared with baseline (4-mm growth threshold). oPVE: growth of the future liver remnant (FLR) by >15% assessed on a presurgical CT scan compared with baseline. oHemorrhage, aneurysm, pseudoaneurysm, pathologic organ: complete occlusion of the target vessel as assessed by angiography during the index procedure. o Hypervascular tumor and vascular anomalies : Correct devascularization of the treated lesion (intentionally complete or incomplete defined at the end of the procedure).	up to 6 moonths, depending on indication
EQ-5D (Stage I and Stage II)	Baseline and follow-up patient's quality of life EQ-5D (unabbreviated: EuroQol 5-dimensions ). Health state index scores generally range from 0 (dead) to 1 (perfect health), with higher scores indicating higher health utility.	up to 6 moonths

Collaborators and Investigators

• Sponsor: LVD Biotech S.L
• Investigators: Principal Investigator: Fernando Gómez, Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: interventional radiology; embolization; liquid embolic agent; endovascular therapy; peripheral vascular embolization
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Congenital Abnormalities; Cardiovascular Abnormalities; Aneurysm; Postoperative Hemorrhage; Hemorrhage; Varicose Veins; Vascular Malformations; Endoleak; Aneurysm, False
• Other Study ID Numbers: amber SEL-P-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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