Trials / Active Not Recruiting
Active Not RecruitingNCT06456125
Safety and Efficacy Of Amber Peripheral Liquid Embolic System
Safety and Efficacy Of Amber Peripheral Liquid Embolic System: a First-in-HumAn & PivotaL Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- LVD Biotech S.L · Industry
- Sex
- All
- Age
- 18 Years – 94 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Vascular Anomalies
- Hemorrhage
- Aneurysm
- Pseudoaneurysm
- Varicose Veins
- Portal Vein Embolization
- Hypervascular Tumor
- Type II Endoleak
- Pathological Organ
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-06-12
- Primary completion
- 2026-07-01
- Completion
- 2026-12-01
- First posted
- 2024-06-13
- Last updated
- 2024-06-17
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT06456125. Inclusion in this directory is not an endorsement.