NCT06456125Active, not recruitingNot Applicable
Safety and Efficacy Of Amber Peripheral Liquid Embolic System: a First-in-HumAn & PivotaL Study
LVD Biotech S.L1 site in 1 country70 target enrollmentStarted: June 12, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Rate of complete vascular occlusion (Stage II)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 94 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Rate of complete vascular occlusion (Stage II)
Time Frame: Embolization procedure day
Rate of complete vascular occlusion as defined by angiography at the end of the procedure.
Peri-procedure serious adverse events related to amber SEL-P (Stage I)
Time Frame: Up to 24 hours after embolization procedure
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.
Secondary Outcomes
- Rate of peri-procedure serious adverse events related to amber SEL-P (Stage II)(Up to 24 hours after embolization procedure)
- Rate of complete vascular occlusion according clinical indication (Stage II)(Embolization procedure day)
- Rate of any peri-procedure adverse events related to amber SEL-P (Stage I)(Up to 24 hours after embolization procedure)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
EMBA Peripheral Embolization Device ("EPED") StudyPeripheral EmbolizationNCT02335788EMBA Medical, Inc.15
Unknown
Early Phase 1
A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic StrokeStroke, IschemicNCT03726814Allife Medical Science and Technology Co., Ltd.12
Unknown
Phase 3
A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 )Insulin Resistance - Type AInsulin Resistance - Type BLipoatrophic Diabetes MellitusInsulin Resistance SyndromeNCT04221152Kobe University8
Terminated
Phase 1
Phase I/II Clinical Study of 1A46 Drug SubstanceAdvanced MalignanciesNCT05987605BioRay Pharmaceutical Co., Ltd.4
Completed
Phase 1
Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry Age Related Macular DegenerationDry Age Related Macular DegenerationNCT01344993Astellas Institute for Regenerative Medicine13