Clinical trials: Chronic Venous Insufficiency
Chronic Kidney Disease Requiring Hemodialysis, End Stage Renal Disease (ESRD)
Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access
The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.
- Trial name
- VENOS-2 (NCT06712251)
- Testing
- Velocity pAVF System
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Venova Medical
End Stage Renal Disease
Evaluation of STARgraft-3 for Hemodialysis
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft.
- Trial name
- NCT05729620
- Testing
- Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 21 people
- Sponsor
- Healionics Corporation
Venous Insufficiency
Safety and Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI)
The External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way venous valve and a sensor that identifies…
- Trial name
- NCT01346553
- Testing
- ESVV device
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- GB-Veintech
Venous Insufficiency
Efficacy and Tolerability of Antistax® in Male and Female Patients Suffering From Chronic Venous Insufficiency
Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location, Pathophysiology (CEAP) Classification: Clinical…
- Trial name
- NCT02191254
- Testing
- Antistax®
- Volunteers
- 245 people
- Sponsor
- Boehringer Ingelheim
End Stage Kidney Disease (ESRD)
STARgraft (10401) Pilot
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft.
- Trial name
- NCT07555717
- Testing
- STARgraft (10401)
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- Healionics Corporation
Venous Ulcer
Clinical Effectiveness of Topical Autologous Platelet Gel for the Treatment of Venous Ulcers
The purpose of this study is to compare the effectiveness of standard venous ulcer care to standard venous ulcer care plus a cell based product made from the patients own blood.
- Trial name
- NCT00273234
- Testing
- Autologous Platelet Gel (APG)
- Where
- 6 sites in United States
- Volunteers
- 70 people
- Sponsor
- National Healing Corporation
Wounds and Injuries
Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies…
- Trial name
- NCT00552643
- Testing
- Suspension of polystyrene beads (POLYHEAL 1), Saline (0.9% NaCl)
- Where
- 6 sites in Israel
- Volunteers
- 60 people
- Sponsor
- Polyheal Ltd.
Venous Leg Ulcer
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
- Trial name
- NCT02680834
- Testing
- Dual Action Pneumatic Compression Device, Multi-Layer Bandaging
- Where
- 18 sites in United States
- Volunteers
- 56 people
- Sponsor
- Tactile Medical
Varicose Veins
LivRelief Varicose Veins Cream in the Treatment of Varicose Veins
Phase IV interventional design where all participants used the test product as per package instructions for 6-weeks. Baseline observations were compared to those collected after 6-weeks of treatment.
- Trial name
- NCT03653793
- Testing
- Natural Health Product: LivRelief Varicose Veins Cream
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- Delivra, 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
Venous Leg Ulcer, Chronic Venous Insufficiency
Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.
- Conditions
- Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer, Venous Ulcer
- Trial name
- NCT02395302
- Testing
- Dual Action Pneumatic Compression
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Tactile Medical
Venous Insufficiency
Efficacy of Antistax® in Improving Microcirculation of the Skin in the Leg in Patients Suffering From Chronic Venous Insufficiency
Study to determine the efficacy and safety of Antistax® film coated tablets in improving microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)
- Trial name
- NCT02191163
- Testing
- Antistax®
- Volunteers
- 71 people
- Sponsor
- Boehringer Ingelheim
Chronic Venous Insufficiency, Hemorrhoids
Efficacy and Tolerability of the Use of Varicell Compared With Daflon
The purpose of this study is to evaluate the efficacy and tolerability of Varicell compared to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal syndrome.
- Trial name
- NCT01321619
- Testing
- Daflon
- Where
- Brazil
- Volunteers
- 102 people
- Sponsor
- Vidfarma Indústria de Medicamentos Ltda.
End-stage Renal Disease
Ellipsys Vascular Access System Registry
Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a…
- Trial name
- NCT03454113
- Testing
- Ellipsys Vascular Access
- Where
- 5 sites in Germany
- Volunteers
- 17 people
- Sponsor
- Medtronic Endovascular
Chronic Venous Insufficiency
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-Canada)
Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity.
- Trial name
- NCT05047302
- Testing
- BlueLeaf Procedure
- Sponsor
- Intervene, Inc.
Venous Leg Ulcer, Venous Ulcer
Tissue Repair Gel in Venous Leg Ulcers in AU/US
The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs).
- Conditions
- Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis
- Trial name
- TRIVIA (NCT06707103)
- Testing
- TR987 0.1% gel + Standard of Care, Standard of care
- Where
- 12 sites in United States, Australia
- Volunteers
- 312 people
- Sponsor
- TR Therapeutics
Chronic Venous Insufficiency
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.
- Trial name
- NCT04253301
- Testing
- InnoVein Valve Treatment
- Where
- 3 sites in Australia
- Volunteers
- 5 people
- Sponsor
- InnoVein
Chronic Venous Insufficiency
Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study
This is a multi-center series assessment with a planned accrual of 70 patients with diagnosed symptomatic primary GSV insufficiency.
- Trial name
- VEINRESET (NCT05926830)
- Testing
- Sonovein Treatment
- Where
- 4 sites in United States, Austria and 1 more
- Volunteers
- 70 people
- Sponsor
- Theraclion
End Stage Kidney Disease (ESRD)
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for…
- Trial name
- AMPLIFI-1 (NCT07211035)
- Testing
- The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation., Standard of Care (AVF creation)
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Amplifi Vascular, Inc.
Chronic Venous Insufficiency
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).
- Trial name
- INFINITE-OUS (NCT03216005)
- Testing
- BlueLeaf System
- Where
- 5 sites in Australia, Canada and 1 more
- Volunteers
- 14 people
- Sponsor
- Intervene, Inc.