Clinical trials: Access and Evaluation
Renal Insufficiency,Chronic
BEACH Trial: Bovine Early Access, Compatibility and Hemostasis Trial
Bovine Early Access, Compatibility, and Hemostasis (BEACH) Trial Study is to evaluate the Safety and Effectiveness of Early Access in Patients Who Require an Arteriovenous Conduit for Hemodialysis using the Artegraft® Collagen…
- Trial name
- BEACH (NCT04146012)
- Testing
- Artegraft® Collagen Vascular Graft™ (Artegraft)
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Artegraft, Inc.
Bleeding
Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
The purpose of this study is to evaluate the safety and efficacy of the Rex Medical Closer™ Vascular Closure System to close the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures with…
- Trial name
- NCT01873898
- Testing
- Rex Medical Closer™ Vascular Closure System
- Where
- Paraguay
- Volunteers
- 30 people
- Sponsor
- Rex Medical
Transapical Transcatheter Aortic Valve Implantation
Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System
A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system.
- Trial name
- NCT01722591
- Testing
- Cardiapex device
- Where
- 2 sites in Germany
- Volunteers
- 38 people
- Sponsor
- Cardiapex Ltd.
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.
Post COVID-19 Syndrome
Intermediate Size Expanded Access Protocol for the Treatment of Post-COVID-19 Syndrome
This is an Intermediate- Size Patient Population Expanded Access Protocol to evaluate the safety and efficacy of HB-adMSCs for the treatment of patients with Post-COVID-19 Syndrome.
- Trial name
- NCT04798066
- Testing
- HB-adMSCs
- 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.)
End Stage Renal Disease
Evaluation of STARgraft-2 for Hemodialysis Access
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft.
- Trial name
- NCT04783779
- Testing
- Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- Healionics Corporation
Iron Deficiency Anemia
Ferrous Acetyl-Aspartate Casein Formulation Evaluation Over Ferrous Sulfate in Iron Deficiency Anemia
The scope of this study is to compare the efficacy of the new oral formulation of Fe-ASP to oral ferrous sulfate in patients with iron deficiency anemia (IDA) for the restoration of decreased circulating Hb.
- Trial name
- ACCESS (NCT03524651)
- Testing
- Ferrous Sulfate, Fe-ASP
- Where
- 3 sites in Greece
- Volunteers
- 60 people
- Sponsor
- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Knee Pain Chronic, Osteo Arthritis Knee
Individual Patient Expanded Access IND of Autologous HB-adMSCS for the Treatment of Bilateral Knee Pain.
This is an Individual Patient Expanded Access IND of autologous adipose derived Mesenchymal Stem Cells with the primary goal of treating 1 individual with bilateral knee pain who has exhausted all treatment options, his condition…
- Trial name
- NCT04604288
- Testing
- HB-adMSC
- Where
- United States
- Sponsor
- Hope Biosciences Research Foundation
Vascular Access, End Stage Renal Disease
A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas
This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and…
- Trial name
- NCT02112669
- Testing
- VasQ
- Where
- 4 sites in Israel, United Kingdom
- Volunteers
- 60 people
- Sponsor
- Laminate Medical Technologies
Hemostasis, Distal Radial Artery Access (dTRA)
Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
This clinical study has been organised to learn more about the safety and use of the TR Band Distal device in patients who have had a heart procedure through a blood vessel in the wrist near the base of the thumb (called distal…
- Trial name
- EASY DISTAL (NCT07888738)
- Testing
- TR Band Distal
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 320 people
- Sponsor
- Terumo Europe N.V.
Essential Tremor
Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with…
- Trial name
- NCT02289560
- Testing
- Transcranial ExAblate
- Where
- 7 sites in United States
- Volunteers
- 61 people
- Sponsor
- InSightec
End Stage Renal Disease, Hemodialysis Access Failure
PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices.
- Trial name
- PReSeRVE-HD (NCT06422871)
- Testing
- HeRO® Graft System or Super HeRO® System
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Merit Medical Systems, Inc.
End-stage Renal Disease, Kidney Failure, Chronic
Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
- Trial name
- NCT01744418
- Testing
- HAVG graft implantation
- Where
- 3 sites in Poland
- Volunteers
- 40 people
- Sponsor
- Humacyte, Inc.
Peripheral Arterial Disease
Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access
The primary objective of this clinical investigation was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon…
- Trial name
- RADIANCY (NCT05399680)
- Testing
- S.M.A.R.T. RADIANZ™ Vascular Stent System, BRITE TIP RADIANZ™ Guiding Sheath, SABERX RADIANZ™ PTA Balloon Catheter
- Where
- 12 sites in Austria, Belgium and 4 more
- Volunteers
- 151 people
- Sponsor
- Cordis US Corp.
System; Lupus Erythematosus
Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
This protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on…
- Trial name
- NCT04907175
- Testing
- HB-adMSCs
- Where
- United States
- Sponsor
- Hope Biosciences Research Foundation
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
Intrauterine Adhesion
Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions Following Endometrial Ablation
The objective of this study is to gain information concerning the acute and longer-term morphological changes within the uterus following endometrial ablation.
- Trial name
- NCT04824430
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Rejoni Inc.
Drug Toxicity
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
Arm 1: Primary Objective: To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100. Arm 2: Primary Objective: To assess the effects of steady-state levels of HPN-100 metabolites (4…
- Trial name
- NCT01135680
- Testing
- HPN-100, Moxifloxacin
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Amgen
Severe Aortic Stenosis
Colibri Transcatheter Aortic Heart Valve System Study
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.
- Trial name
- NCT04029844
- Testing
- Colibri TAVI System
- Where
- 5 sites in France, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Colibri Heart Valve LLC