Clinical trials: Venous Vascular Closure
Surgical Wound
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures…
- Trial name
- NCT03573206
- Testing
- Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Cardiva Medical, Inc.
Vascular Closure Devices
xDot Access Management System Early Feasibility Study
The objective of this study is to demonstrate safety and investigate effectiveness of the xDot Access Management System (AMS) for closure of large bore femoral-arterial and femoral-venous access sites.
- Trial name
- NCT07464353
- Testing
- xDot Access Management System (AMS)
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- xDot Medical, Inc
Venous Reflux
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous…
- Trial name
- NCT03820947
- Testing
- VenaSeal™ System, Endothermal Ablation (ETA), Surgical Stripping
- Where
- 32 sites in United States, Australia and 8 more
- Volunteers
- 506 people
- Sponsor
- Medtronic Endovascular
Venous Ulcer, Infection
Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers
Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following…
- Trial name
- NCT01396304
- Testing
- Restore Calcium Alginate Dressing, AquaCel Ag Wound Dressing
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- Hollister Wound Care LLC
Leg Ulcers, Diabetic Foot Ulcer
Vacuum Compression Therapy for Chronic Lower Limb Ulcers
The goal of this clinical trial is to learn if vacuum compression therapy added to standard care improves wound healing in adults with chronic lower limb ulcers.
- Conditions
- Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
- Trial name
- NCT07737184
- Testing
- Vacuum Compression Therapy (VCT), Standardized Wound Care
- Where
- Czechia
- Volunteers
- 50 people
- Sponsor
- BTL Industries Ltd.
Varicose Veins
Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose Veins
The goal of this clinical trial is to evaluate the effectiveness and safety of the endovenous radiofrequency ablation closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd.
- Trial name
- NCT04671641
- Testing
- radiofrequency ablation
- Where
- 5 sites in China
- Volunteers
- 176 people
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
Venous Leg, Venous Leg Ulcer (VLU)
Evaluating the Durability of Closure for Venous Leg Ulcers
The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.
- Conditions
- Venous Leg, Venous Leg Ulcer (VLU), Venous Leg Ulcer, Venous Ulcer
- Trial name
- THORSDOTTIR (NCT06697925)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Kerecis Ltd.
Atrial Fibrillation (AF), Bleeding
Concomitant PFA Bsaed PVI Plus LAAC
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy…
- Conditions
- Atrial Fibrillation (AF), Bleeding, Stroke
- Trial name
- COCONUT_2 (NCT07450755)
- Testing
- Interventional LAA Closure, Pulmonary vein isolation
- Volunteers
- 150 people
- Sponsor
- Asklepios proresearch
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact®
Study is to provide a blinded assessment of wound closure status utilizing photographs collected as per standard of care (SOC) during the AAA RCT (WC-22-435).
- Trial name
- NCT07308678
- Where
- Germany
- Volunteers
- 105 people
- Sponsor
- ConvaTec Inc.
Vascular Closure Devices
xDot Access Management System Pivotal Study
The objective of this study is to establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure.
- Trial name
- NCT07719244
- Testing
- xDot Access Management System (AMS)
- Volunteers
- 266 people
- Sponsor
- xDot Medical, Inc
Chronic Venous Insufficiency, CVI, Venous Malformations
Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery
The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the…
- Conditions
- Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers, Klippel-Trenaunay Syndrome
- Trial name
- HIFIVE (NCT06642051)
- Testing
- High Intensity focused ultrasound
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Sonablate
Chronic Wounds, Venous Leg Ulcer (VLU)
Evaluation of Cold Plasma in Chronic Wound Healing
The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds.
- Conditions
- Chronic Wounds, Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- PLASANAGENESIS (NCT06964048)
- Testing
- Cold Atmospheric Plasma treatment
- Volunteers
- 66 people
- Sponsor
- Plasana Medical
Venous Vascular Closure
Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression
ReliaSeal is a clinical trial designed to evaluate safety and efficacy of use of MYNX CONTROL™ Venous Vascular Closure Device 6F-12F vs.
- Trial name
- ReliaSeal (NCT05554471)
- Testing
- MYNX CONTROL™ Venous Vascular Closure Device 6F-12F
- Where
- 14 sites in United States
- Volunteers
- 352 people
- Sponsor
- Cordis US Corp.
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Surgical Wound
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA)…
- Trial name
- NCT03193021
- Testing
- Cardiva Mid-Bore VVCS, Manual compression
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Cardiva Medical, Inc.
Large Hole Percutaneous Venous Closure
PerQseal® Elite Venous Clinical Study (ELITE-Venous)
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F)…
- Trial name
- ELITE-Venous (NCT06007339)
- Testing
- PerQseal ELITE
- Where
- Netherlands
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited
Leg Ulcers, Leg Ulcers Venous
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Chronic lower limb ulcers, particularly those of venous etiology, are difficult-to-heal wounds that severely affect patients' quality of life. Adequate tissue oxygenation is essential for wound healing.
- Trial name
- NCT07901517
- Testing
- Vacuum Compression Therapy (VCT), Standard Wound Care
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- BTL Industries Ltd.
Diabetic Macular Edema, Branch Retinal Vein Occlusion
EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)
This is a randomized, double-masked, multicenter, study to evaluate the efficacy, safety, and tolerability of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections.
- Conditions
- Diabetic Macular Edema, Branch Retinal Vein Occlusion, Glaucoma/Closed Angle Glaucoma
- Trial name
- CLEAN (NCT05127525)
- Testing
- IRX-101, Control
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- iRenix Medical, Inc.
Acute Myocardial Infarction, Restenoses, Coronary
Abbott Vascular Medical Device Registry
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use…
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism
- Trial name
- AV-MDR (NCT04573660)
- Testing
- Coronary and peripheral stents, Pacing catheters, Vascular plugs
- Where
- 37 sites in United States, Australia and 12 more
- Volunteers
- 3,784 people
- Sponsor
- Abbott Medical Devices
Venous Vascular Closure, Electrophysiology Study
Mobilization and Outcomes After Venous Closure
The primary objective of this post-market registry is to collect real-world outcomes and evaluate usage practice of MYNX CONTROL™ VENOUS (MCV) Vascular Closure Device (VCD) 6F-12F in sealing femoral venous access sites in…
- Trial name
- MOVE (NCT07246902)
- Testing
- MYNX CONTROLTM VENOUS Vascular Closure Device
- Where
- 9 sites in United States
- Volunteers
- 339 people
- Sponsor
- Cordis US Corp.