Clinical trials: Access and Evaluation
Dialysis; Complications, Vascular Access Complication
Access Cannulation Trial II
This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating…
- Trial name
- ACT II (NCT05490225)
- Testing
- VenaSure
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Voyager Biomedical
Vascular Closure Device, Femoral Arteriotomy Closure
Initial Safety and Preliminary Efficacy of the Novelrad Vascular Closure System (NVCS)
This study evaluates the initial safety and preliminary efficacy of the Novelrad Vascular Closure System (NVCS), a suture-mediated vascular closure system, in achieving post-procedure hemostasis in subjects undergoing…
- Conditions
- Vascular Closure Device, Femoral Arteriotomy Closure, Femoral Access Site Closure
- Trial name
- NCT07858903
- Testing
- Novelrad Vascular Closure System (NVCS)
- Where
- 3 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Novelrad Ltd.
Type 2 Diabetes
Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
A multi-center, randomized, parallel, interventional, open label trial to compare Hemoglobin A1C-lowering effect of conventional treatment and Smart Care Service in patients with type 2 diabetes.
- Trial name
- Smart-DM (NCT01345435)
- Testing
- Telemonitoring group, Telemonitoring & Telemedicine, SMBG
- Where
- 4 sites in South Korea
- Volunteers
- 417 people
- Sponsor
- CHANGHEE LEE
Arrhythmias, Cardiac, Atrial Fibrillation
To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.
The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode…
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Heart Diseases
- Trial name
- NCT06358391
- Testing
- TS-RF Transseptal Needle, BRK Transseptal Needle
- Where
- South Korea
- Volunteers
- 70 people
- Sponsor
- Starmed
Gather Feasibility Data and User Feedback on Use of a Device in Vivo on Pregnant Volunteers in Their 2nd and 3rd Trimester
Vscan Access R2 Feasibility Evaluation
This study is being done to evaluate if the Vscan Access R2 Ultrasound System can measure Fetal Heart Rate (FHR) in humans when compared against a reference device (GE Corometrics 170 Series Fetal Monitor), and to gather feedback…
- Trial name
- NCT03617419
- Testing
- GE VScan Access R2 Ultrasound System, GE Corometrics 170 Series Fetal Monitor
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
End Stage Renal Disease
Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence
Patients in renal failure on hemodialysis depend on adequate and sustained vascular access. This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE) graft.
- Trial name
- AdV-VANTAGE (NCT00895479)
- Testing
- Graft placement surgery plus Trinam therapy
- Where
- 12 sites in United States
- Volunteers
- 250 people
- Sponsor
- Ark Therapeutics Ltd
Surgical Wound
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
- Trial name
- Closer (NCT02136004)
- Testing
- Closer VSS
- Where
- 12 sites in United States
- Volunteers
- 220 people
- Sponsor
- Rex Medical
Arteriovenous Fistula Stenosis, Arteriovenous Fistula
A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)
A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis
- Conditions
- Arteriovenous Fistula Stenosis, Arteriovenous Fistula, Vascular Access
- Trial name
- NCT06639451
- Testing
- RANGER™ Paclitaxel Coated Balloon Catheter
- Where
- 8 sites in Japan
- Volunteers
- 186 people
- Sponsor
- Boston Scientific Corporation
Arrhythmia
Perclose Multi-Access Duplex Ultrasound (DUS) Study
The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and…
- Trial name
- NCT04904809
- Testing
- Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Abbott Medical Devices
Polyneuropathies
Individual Patient Expanded Access IND to Treat Polyneuropathy
This Individual Patient Expanded Access IND has been created as requested by an 58-year-old man who suffers from Polyneuropathy due to Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin abnormalities…
- Trial name
- NCT04064983
- Testing
- HB-adMSCs
- Where
- United States
- Sponsor
- Hope Biosciences Research Foundation
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System
The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with…
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Poor Vascular Access
- Trial name
- NCT06037265
- Testing
- PAVmed PortIO™ Intraosseous Infusion System
- Where
- 4 sites in Colombia
- Volunteers
- 15 people
- Sponsor
- PAVmed Inc.
Valid MeSH Conditiongs
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Use these resources to provide understandable information about this study to patients, families, and health care providers:
- Trial name
- NCT07840729
- Testing
- JMT206 injection, Semaglutide injection
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shanghai JMT-Bio Inc.
HIV I Infection, HIV-2 Infection
Access HIV Ag/Ab Combo Assay - European Union (EU) Clinical Trial Protocol
The objective of this study is the collection and testing of clinical samples to determine the clinical performance of the Access HIV Ag/Ab Combo assay on the DxI 9000 Access Immunoassay Analyzer
- Trial name
- HIV-EU-11-18 (NCT04971343)
- Testing
- Access HIV_blood donor, Access HIV_Hospitalized patient, Access HIV_known HIV-1 antibody positives
- Where
- 6 sites in France
- Volunteers
- 8,650 people
- Sponsor
- Beckman Coulter, Inc.
Atrial Fibrillation
Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF
The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation and persistent atrial…
- Trial name
- NCT02521896
- Testing
- Steerable Sheath System
- Volunteers
- 8 people
- Sponsor
- Kalila Medical
Chronic Inflammatory Demyelinating Polyneuropathy
An Expanded Access IND for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This is an Individual Patient Expanded Access IND to evaluate the safety and preliminary efficacy of autologous HB-adMSCs for treating a single patient Chronic Inflammatory Demyelinating Polyneuropathy, CIDP.
- Trial name
- NCT04825626
- Testing
- HB-adMSCs
- Where
- United States
- Sponsor
- Hope Biosciences Research Foundation
Arteriovenous Fistula
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation…
- Trial name
- NCT01806545
- Testing
- SRM003, Participating Site's standard practice
- Where
- 47 sites in United States
- Volunteers
- 64 people
- Sponsor
- Shire
Prostate Cancer
Study to Gather Information About the Use of Healthcare Services and the Way the Disease is Cared for in Canadian Patients With Prostate Gland Cancer Which Spread Throughout the Body
Study to gather information about the optimal placement of Ra-223 in the order of different treatments in terms of the effect on patients and in terms of the use of healthcare services for the treatment of Canadian patients with…
- Trial name
- REACTIVATE (NCT04281147)
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223)
- Where
- Canada
- Volunteers
- 4,301 people
- Sponsor
- Bayer
Autoimmune Diseases
Phase 1 Study Accessing the Safety and Tolerability of CBP-307
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CBP-307 following oral single and multiple escalating dose administration in healthy subjects.
- Trial name
- NCT02280434
- Testing
- CBP-307
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Connect Biopharm LLC
Sinusitis, Chronic Rhinosinusitis
Clinical Evaluation of the Ethmoid Sinus Spacer
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
- Trial name
- SPACER (NCT01054703)
- Testing
- Ethmoid Sinus Spacer
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Integra LifeSciences Corporation