Clinical trials: Access and Evaluation
Hypertension
Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Live in Patients With Essential Hypertension
Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's quality of life scores.
- Trial name
- MicCAT (NCT02242370)
- Testing
- Low dose of telmisartan, High dose of telmisartan
- Volunteers
- 3,045 people
- Sponsor
- Boehringer Ingelheim
Renal Failure, End Stage Renal Disease
Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
- Conditions
- Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
- Trial name
- NCT02644941
- Testing
- Human Acellular Vessel (HAV), ePTFE graft
- Where
- 38 sites in United States, Germany and 4 more
- Volunteers
- 355 people
- Sponsor
- Humacyte, Inc.
Vascular Access Complication
Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.
- Trial name
- NCT00914069
- Testing
- RIVS vascular access, Conventional vascular access
- Where
- 3 sites in United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Congenital Muscular Dystrophy Due to Lamin A/C Mutation
HBCMD01- Expanded Access for the Treatment of Congenital Muscular Dystrophy.
This individual patient expanded access IND is requested for a patient diagnosed with LMNA-related congenital muscular dystrophy (L-CMD).
- Trial name
- NCT05154851
- Testing
- HB-adMSCs
- Where
- United States
- Sponsor
- Hope Biosciences Research Foundation
The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal
Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable VCD and Perclose® ProGlide SMC System
It is purposed to verify a superiority of the Fastseal® Bioabsorbable Vascular Access Closure System through effectiveness and safety confirmation of hemostasis (TTH; Time to hemstasis) and ambulation (TTA; Time to ambulation) at…
- Trial name
- NCT01597570
- Testing
- Vascular Closure Device
- Where
- 2 sites in South Korea
- Volunteers
- 52 people
- Sponsor
- Taewoong Medical Co., Ltd.
Carcinoma, Renal Cell
Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program
This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or…
- Trial name
- NCT01412671
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- Japan
- Volunteers
- 117 people
- Sponsor
- Bayer
Heart Failure, Congestive Heart Failure
Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
- Conditions
- Heart Failure, Congestive Heart Failure, Chronic Heart Disease, CHF
- Trial name
- FIX-HF-5CA (NCT03102437)
- Testing
- Optimizer Smart System
- Where
- 17 sites in United States
- Volunteers
- 106 people
- Sponsor
- Impulse Dynamics
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.
Spinal Cord Injuries
Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Spinal Cord Injury
HBSCI02: This protocol is part of an FDA Individual Patient Non-emergency Expanded Access Request submitted on behalf of a 38-year-old father and husband who on August 4, 2017 at about 4:30pm, slipped off a boat head-first while…
- Trial name
- NCT04064957
- Testing
- HB-adMSCs
- Where
- United States
- Sponsor
- Hope Biosciences Research Foundation
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
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
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
Multiple System Atrophy
"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs (Hope Biosciences - Adipose Derived Mesenchymal Stem Cells) for the Treatment of Multiple System Atrophy."
This expanded access protocol is part of IND 32226 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of Multiple System Atrophy for up to 7 adult patients who pass…
- Trial name
- NCT07238062
- Testing
- HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells
- Where
- United States
- Sponsor
- Hope Biosciences Research Foundation
Microsurgery, Lymphedema
CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System
The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery.
- Conditions
- Microsurgery, Lymphedema, Free Tissue Transfer
- Trial name
- CONNECT (NCT06866197)
- Testing
- Symani Surgical System
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- MMI (Medical Microinstruments, Inc.)
HIV Infections
TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.
The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) regimens, and to evaluate the…
- Trial name
- NCT00245739
- Testing
- TMC-114
- Where
- 394 sites in United States, Belgium and 20 more
- Sponsor
- Tibotec Pharmaceuticals, Ireland
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