Vascular AnomaliesOPALNCT06456125
Safety and Efficacy Of Amber Peripheral Liquid Embolic System
A study testing amber SEL-P Peripheral Liquid Embolic System in people with Vascular Anomalies and Hemorrhage, run by LVD Biotech S.L at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 94 years
- Conditions the study is for
- Vascular Anomalies, Hemorrhage, Aneurysm
- What is being tested?
- amber SEL-P Peripheral Liquid Embolic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jun 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy Of Amber Peripheral Liquid Embolic System: a First-in-HumAn & PivotaL Study
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.
- Conditions
- Vascular Anomalies, Hemorrhage, Aneurysm, Pseudoaneurysm, Varicose Veins, Portal Vein Embolization
- Being tested
- amber SEL-P Peripheral Liquid Embolic System
- Keywords
- liquid embolic agent, peripheral vascular embolization, embolization, endovascular therapy, interventional radiology
- Medical subject headings
- Vascular Malformations, Hemorrhage, Aneurysm, Aneurysm, False, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amber SEL-P Peripheral Liquid Embolic SystemDevice
Transcatheter arterial or venous embolization with the liquid embolic agent amber SEL-P embolization across seven different indications for peripheral embolization.
| Study group | Role | What they receive |
|---|---|---|
| amber SEL-P Treatment | Experimental | 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. Receives: Device: amber SEL-P Peripheral Liquid Embolic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Embolization procedure day
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: Up to 24 hours after embolization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start12 Jun 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AnomaliesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LVD Biotech S.L
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando Gómez, Principal investigator, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456125
- Sponsor's protocol ID
- amber SEL-P-01
- Acronym
- OPAL
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Of Amber Peripheral Liquid Embolic System: a First-in-HumAn & PivotaL Study
- ClinicalTrials.gov ID
- NCT06456125
- Acronym / sponsor ID
- OPAL / amber SEL-P-01
- Conditions
- Vascular Anomalies, Hemorrhage, Aneurysm, Pseudoaneurysm, Varicose Veins, Portal Vein Embolization
- Keywords
- liquid embolic agent, peripheral vascular embolization, embolization, endovascular therapy, interventional radiology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- LVD Biotech S.LIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| amber SEL-P Treatment | Experimental | Device: amber SEL-P Peripheral Liquid Embolic SystemPatients 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. |
Who may qualify
- Ages
- 18 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged ≥ 18 and < 95 years presenting with one of the following indications:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amber SEL-P Peripheral Liquid Embolic SystemTranscatheter arterial or venous embolization with the liquid embolic agent amber SEL-P embolization across seven different indications for peripheral embolization. | Device | amber SEL-P Treatment |
Primary outcome
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.
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.
3 secondary outcomes
Rate of any peri-procedure adverse events related to amber SEL-P (Stage I)
Time frame: Up to 24 hours after embolization procedure
Rate of complete vascular occlusion according clinical indication (Stage II)
Time frame: Embolization procedure day
Rate of peri-procedure serious adverse events related to amber SEL-P (Stage II)
Time frame: Up to 24 hours after embolization procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Gómez principal investigator
Hospital Universitario La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amber SEL-P Peripheral Liquid Embolic System in people with Vascular Anomalies and Hemorrhage, run by LVD Biotech S.L at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-procedure serious adverse events related to amber SEL-P (Stage I) (time frame: Up to 24 hours after embolization procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.