An interventional study of amber SEL-P Peripheral Liquid Embolic System in Vascular Anomalies, Hemorrhage and Aneurysm, sponsored by LVD Biotech S.L. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years to 94 Years. Per ClinicalTrials.gov, last updated 2024-06-17.
Sponsored by LVD Biotech S.L · Not applicable, Interventional, and Treatment
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.
79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.
This study's planned enrollment of 70 is above the median of 55 across 49 interventional studies indexed under Vascular Malformations.
Browse Vascular Malformations studies →This is the only study on the registry with LVD Biotech S.L as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients aged ≥ 18 and \< 95 years presenting with one of the following indications:
Varicose vein embolization:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: amber SEL-P Peripheral Liquid Embolic System
Transcatheter arterial or venous embolization with the liquid embolic agent amber SEL-P embolization across seven different indications for peripheral embolization.
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.
Time frame: 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.
Time frame: Embolization procedure day
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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 24 hours after embolization procedure
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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Embolization procedure day
Any Serious Adverse Events (Stage I and Stage II)
Total number of any serious adverse events
Time frame: up to 6 moonths
Any Adverse Events (Stage I and Stage II)
otal number of any adverse events
Time frame: up to 6 moonths
Survival rate (Stage I and Stage II)
Survival rate
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Embolization procedure day
Volume of amber SEL-P (Stage I and Stage II)
Mean volume of amber SEL-P used during the index procedure
Time frame: 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
Time frame: Embolization procedure day
Degree of occlusion (Stage I and Stage II)
Mean degree of occlusion of the target vessel(s).
Time frame: Embolization procedure day
Re-interventions (Stage I and Stage II)
Total number of re-interventions for the study procedure.
Time frame: 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).
Time frame: 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.
Time frame: up to 6 moonths
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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