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

LVD Biotech S.L

Status: Active, not recruiting

Conditions: Hypervascular Tumor; Pseudoaneurysm; Aneurysm; Hemorrhage; Portal Vein Embolization; Pathological Organ; Vascular Anomalies; Varicose Veins; Type II Endoleak

Treatments: Device: amber SEL-P Peripheral Liquid Embolic System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06456125

amber SEL-P-01

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 94 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

amber SEL-P Treatment

Experimental group

Description:

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.

Treatment:

Device: amber SEL-P Peripheral Liquid Embolic System