Safety and Efficacy Of Amber Peripheral Liquid Embolic System (NCT06456125) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Efficacy Of Amber Peripheral Liquid Embolic System
Spain70 participantsStarted 2024-06-12
Plain-language 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.
Who can participate
Age range18 Years – 94 Years
SexALL
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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 …
What they're measuring
1
Peri-procedure serious adverse events related to amber SEL-P (Stage I)
Timeframe: Up to 24 hours after embolization procedure