Clinical trials: Access and Evaluation
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
Osteoarthritis, Knee
Patients' Perceptions of Assessment and Treatment of Knee Osteoarthritis in Primary Care
Background: To diagnose osteoarthritis (OA), Swedish guidelines recommend an overall assessment including patient history, symptoms, and clinical findings. However, diagnostic radiography is not recommended when assessing OA.
- Trial name
- NCT05566925
- Testing
- Direct access to physiotherapist for assessment, diagnosis and treatment.
- Where
- 2 sites in Sweden
- Volunteers
- 15 people
- Sponsor
- Vastra Gotaland Region
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.
Pediatric Cancer
Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray
The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports. Participants will receive either the spray or cream prior to port access and rate pain on a scale.
- Trial name
- NCT06023368
- Testing
- Num Vapocoolant Spray, EMLA Cream
- Where
- United States
- Sponsor
- Marianne Hutti
Homeless and Low Incomes People, Refugees
Oral Evaluation by the Nurses From the Office of Access to Healthcare ("PASS") for Vulnerable People - PASSDENT Study
Oral health is defined as the state of being free from dental or periodontal diseases and discomfort of oral cavity. WHO considers that oral hygiene is a major public health problem whatever the countries (developed, developing…
- Trial name
- PASSDENT (NCT03493750)
- Testing
- Oral and dental evaluation
- Where
- 7 sites in France
- Volunteers
- 183 people
- Sponsor
- Centre Hospitalier Annecy Genevois
Sensorineural Hearing Loss
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
- Trial name
- EAR2OS (NCT03746613)
- Testing
- HEARO
- Where
- Belgium
- Volunteers
- 3 people
- Sponsor
- Prof. Vedat Topsakal
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.
Arteriovenous Fistula
Role of Color Doppler Ultrasonography in Assessment of Vascular Access Surveillance in Hemodialysis Patients.
The aim of this study is to provide an overview of the possible applications of DUS during the maturation and postoperative follow-up of vascular access, with particular emphasis to establish a relationship between doppler…
- Trial name
- NCT04196478
- Testing
- doppler ultrasound
- Volunteers
- 120 people
- Sponsor
- Assiut University
Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD)
Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients
Pulmonary hypertension (PH) is a frequent and clinically significant complication in patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis (HD).
- Conditions
- Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD), Hemodialysis Patients, Volume Overload
- Trial name
- EU-PHASE-HD (NCT07676786)
- Testing
- Observational Assessment
- Where
- 2 sites in Romania
- Volunteers
- 30 people
- Sponsor
- Stefan Lujinschi
Cardiovascular Disease
mHealth Interventions to Improve Access and Coverage of Uninsured People With High Cardiovascular Risk in Argentina.
Cardiovascular disease (CVD) accounts for approximately one-third of Argentina's deaths. Despite the availability of management and treatment for CVD which is offered to the uninsured population at government primary care clinics…
- Trial name
- mHealth (NCT02913339)
- Testing
- mHealth Risk Assessment
- Where
- Argentina
- Volunteers
- 756 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
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
Opioid Dependence, Overdose
Effects on Mortality and Clinical Course of a Patient's Choice Model for Opioid Maintenance Treatment for Opioid Dependence - Evaluation of a System Enabling a Large Expansion of Treatment Providers and Treatment Access
Opioid dependence, for example involving addiction to injected or inhaled heroin or similar compounds, is associated with high mortality, typically from opioid overdose, and causes major physical and mental health complications…
- Trial name
- NCT05678036
- Testing
- Opioid maintenance treatment
- Where
- Sweden
- Volunteers
- 2,500 people
- Sponsor
- Region Skane
Safety, Efficacy
Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy
This study aims to evaluate and compare the safety, efficacy, and clinical outcomes of papillary and non-papillary renal access during percutaneous nephrolithotomy (PCNL), and to determine whether non-papillary puncture can be…
- Conditions
- Safety, Efficacy, Papillary, NonPapillary
- Trial name
- NCT07855354
- Testing
- Papillary access puncture, Non-papillary access puncture
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Ain Shams University
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.
Pregnancy
Michigan Contraceptive Access, Research, and Evaluation Study: Phase 1
M-CARES will use large-scale administrative data complemented by follow-up surveys and a randomized control trial (RCT) to estimate the causal impact of greater financial access to contraception on a comprehensive set of…
- Trial name
- M-CARES (NCT03673007)
- Testing
- Gift card to be used for contraceptives that is valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019), Gift card to be used for contraceptives that is valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)
- Where
- 9 sites in United States
- Volunteers
- 4,633 people, healthy volunteers welcome
- Sponsor
- University of Michigan
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