Clinical trials: Venous Vascular Closure
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.
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
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.
Occlusions Vein, Chronic Venous Insufficiency
Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins
The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.
- Trial name
- CASS (NCT03835559)
- Testing
- Cyanoacrylate closure, Surgical stripping
- Where
- 2 sites in South Korea
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Kyung Hee University Hospital at Gangdong
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
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
Varicose Veins, Venous Reflux
Lake Washington Vascular VenaSeal™ Post-Market Evaluation
New-WAVES Study seeks to expand understanding/results from prior study (NCT02585726). Assessing both clinical outcomes and patient satisfaction after treatment with Venaseal/Cyanoacrylate Adhesive Closure System
- Trial name
- New-WAVES (NCT04146168)
- Testing
- Ultrasound
- Where
- 3 sites in United States
- Volunteers
- 124 people
- Sponsor
- Lake Washington Vascular
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
Varicose Ulcer
Negative Pressure Vs. Compression in Venous Ulcers
This study randomises patients with venous leg ulcers, to be managed either using conventional compression bandages or a bridged vacuum assisted closure system under compression.
- Trial name
- NCT03688841
- Testing
- Bridged V.A.C.® with compression therapy, Conventional Compression Therapy
- Where
- Ireland
- Volunteers
- 50 people
- Sponsor
- Western Vascular Institute, Ireland
Atrial Fibrillation
Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation
Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot…
- Trial name
- Style-AF (NCT05563142)
- Testing
- deploying vascular closure device versus manual compression
- Where
- 3 sites in Germany
- Volunteers
- 125 people
- Sponsor
- University of Luebeck
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.
Venous Stasis Ulcers
Provant Therapy of Venous Stasis Ulcer Trial
This pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to improper functioning of valves in the veins…
- Trial name
- NCT01050023
- Testing
- Provant Device (Wound Therapy System), Provant Device - Inactive
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Southern California Institute for Research and Education
Varicose Veins
Non-Inferiority Clinical Evaluation of a Novel Varicose Vein Closure Adhesive System for Lower Extremity Varicose Veins
A prospective, multicenter, randomized, controlled, non-inferiority trial in which patients with great saphenous vein varicosities were treated with either the novel vein closure system (Shanghai Tendfo Medical Technology Co.…
- Trial name
- NCT07827339
- Testing
- CAC: Varicose Vein Closure Adhesive System (Shanghai Tendfo Medical Technology Co., Ltd.), RFA: the ClosureRFG™/ClosureFast™ system (Medtronic Inc.)
- Where
- 6 sites in China
- Volunteers
- 179 people
- Sponsor
- Shanghai TENDFO Medical Technology Co., Ltd.
Chronic Venous Insufficiency C2 or Higher
Prospective Multicentric Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diode Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.
Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency…
- Trial name
- VNUS vs TULIP (NCT01722019)
- Testing
- Tulip fiber, VNUS closure fast
- Where
- 3 sites in Belgium
- Volunteers
- 280 people
- Sponsor
- University Hospital, Ghent
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.
Vascular Closure, Pacemaker Implantation
Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.
The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker…
- Conditions
- Vascular Closure, Pacemaker Implantation, Leadless Pacemaker
- Trial name
- PERCLOSE-LP (NCT06837870)
- Testing
- percutaneous suture mediated closure, Figure of Eight Suture
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Massachusetts, Worcester
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
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 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.