Safety and Efficacy Of Amber Peripheral Liquid Embolic System
NCT Number: NCT06456125
Acronym: OPAL
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vascular Anomalies|Hemorrhage|Aneurysm|Pseudoaneurysm|Varicose Veins|Portal Vein Embolization|Hypervascular Tumor|Type II Endoleak|Pathological Organ
Interventions: DEVICE: amber SEL-P Peripheral Liquid Embolic System
Sponsor: LVD Biotech S.L
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-12
Completion Date: 2026-12
Locations: Hospital Universitario Y Politécnico La Fe, Valencia, Spain

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.

Primary Outcome Measures: 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: 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: 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