Safety and Efficacy Of Amber Peripheral Liquid Embolic System

Trial Title: Safety and Efficacy Of Amber Peripheral Liquid Embolic System

NCT ID: NCT06456125

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

Conditions: Official terms:
Varicose Veins
Endoleak
Vascular Malformations
Aneurysm, False
Hemorrhage

Conditions: Keywords:
liquid embolic agent
peripheral vascular embolization
embolization
endovascular therapy
interventional radiology

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: amber SEL-P Peripheral Liquid Embolic System
Description: Transcatheter arterial or venous embolization with the liquid embolic agent amber SEL-P embolization across seven different indications for peripheral embolization.
Arm group label: amber SEL-P Treatment

Summary: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 94 Years

Healthy volunteers: No

Locations:

Facility:
Name: Hospital Universitario Y Politécnico La Fe

Address:
City: Valencia
Country: Spain

Start date: June 12, 2024

Completion date: December 2026

Lead sponsor:
Agency: LVD Biotech S.L
Agency class: Industry

Source: LVD Biotech S.L

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06456125