Clinical trials: Access and Evaluation
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.
Schizophrenia Spectrum & Other Psychotic Disorders
PACT for Individuals With Serious Mental Illness
People with serious mental illness have difficulty making good use of primary care, and die, on average, years earlier than others in the population.
- Trial name
- SMI-PACT (NCT01668355)
- Testing
- Patient Aligned Care Team (PACT)
- Where
- 3 sites in United States
- Volunteers
- 331 people
- Sponsor
- VA Office of Research and Development
Chronic Disease, Patient Outcome Assessment
Consumer Health IT Tools: Impact on Experience, Access, and Outcomes for Patients With Complex Chronic Conditions
Patient use of health IT tools to interact with healthcare providers and delivery systems, including exchanging secure messages with their medical providers and using other web-based tools, has great potential to increase patient…
- Conditions
- Chronic Disease, Patient Outcome Assessment, Electronic Health Records
- Trial name
- NCT02292940
- Volunteers
- 168,477 people
- Sponsor
- Kaiser Permanente
Complication of Renal Dialysis, End Stage Renal Disease
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS (NCT02513303)
- Testing
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- Where
- 4 sites in United States
- Volunteers
- 269 people
- Sponsor
- Vascular Therapies, Inc.
Contraceptive Usage, Contraception
SexHealth Mobile: Integrating a Mobile Clinic and a Point-of-care Contraception Counseling and Access
Pilot study aims to evaluate the effectiveness of "SexHealth Mobile" and improve access to highly effective contraception among women with substance use disorder (SUD) with "SexHealth Mobile" intervention.
- Trial name
- NCT04227145
- Testing
- SexHealth Mobile
- Where
- 4 sites in United States
- Volunteers
- 98 people
- Sponsor
- Children's Mercy Hospital Kansas City
Diabetes Mellitus, Type 2
Diabetes Disparities: Texting to Extend Treatment (DD-TXT)
One way to help Veterans improve their diabetes control is through the use of technology to help provide information, motivation, and reminders necessary to support diabetes self-management.
- Trial name
- DD-TXT (NCT04227379)
- Testing
- Intervention 1- DSMS+, Comparison - DSMS
- Where
- 3 sites in United States
- Volunteers
- 366 people
- Sponsor
- VA Office of Research and Development
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
Renal Failure, End Stage Renal Disease
Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis
This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).
- Conditions
- Renal Failure, End Stage Renal Disease, Vascular Access, Hemodialysis
- Trial name
- NCT04135417
- Testing
- HAV
- Where
- 2 sites in Poland
- Volunteers
- 30 people
- Sponsor
- Humacyte, Inc.
Surgical Wound, Vascular Access
The AMBULATE EXPAND Trial: VASCADE MVP XL for Femoral Venous Access Sites, 16-17F OD
A Multi-Center, Prospective, Single Arm, Pivotal Trial to Evaluate the Safety and Efficacy of the VASCADE MVP® XL Venous Vascular Closure System (VVCS) for the Management of the Femoral Venotomy After Catheter-Based Interventions…
- Trial name
- NCT06615154
- Testing
- VASCADE MVP XL (800-1014XL)
- Volunteers
- 85 people
- Sponsor
- Haemonetics Corporation
Dementia, Chronic Disease
Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)
The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over…
- Conditions
- Dementia, Chronic Disease, Neoplasm Metastasis, Lung Neoplasms
- Trial name
- PICSI-H (NCT04283994)
- Testing
- Survey-based Patient/Clinician Jumpstart, EHR-based Clinician Jumpstart
- Where
- 3 sites in United States
- Volunteers
- 756 people
- Sponsor
- University of Washington
Cigarette Smoking
E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services
This randomized controlled trial evaluated the feasibility and potential efficacy of 1) e-cigarette switching (EC) or 2) e-cigarette switching + financial incentives for combustible cigarette cessation (EC+FI)
- Trial name
- EXCHANGE (NCT03743532)
- Testing
- E-cigarette Switching, Financial Incentives
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Hypertension, Diabetes
Assessing Open Access Audio
The medical encounter can be overwhelming in term of the amount of information discussed, its technical nature, and the anxiety it can generate.
- Trial name
- OAA (NCT04452331)
- Testing
- Open Access Audio, No Access, Patient and Provider Aware of Recording, No Access, Provider Unaware of Recording
- Where
- 2 sites in United States
- Volunteers
- 1,553 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
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
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
Heart Transplant
Donor After Circulatory Death Heart CAP Trial
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
- Trial name
- NCT04615182
- Testing
- Transplant
- Where
- 25 sites in United States
- Volunteers
- 90 people
- Sponsor
- TransMedics
Psoriasis
A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis
To evaluate the safety profile, the effectiveness and the economic impact of adalimumab when used for the treatment of subjects with active plaque psoriasis who have not adequately responded to prior psoriasis therapy.
- Trial name
- PRIDE (NCT00513370)
- Testing
- Humira (adalimumab)
- Where
- 27 sites in Canada
- Volunteers
- 203 people
- Sponsor
- Abbott
Vascular Diseases, Peripheral Arterial Disease
Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery
The objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction procedure.
- Conditions
- Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder), Carotid Artery Diseases
- Trial name
- PHOTO-V (NCT03669042)
- Testing
- PhotoFix
- Where
- 9 sites in United States
- Volunteers
- 94 people
- Sponsor
- Artivion Inc.
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip…
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure
- Trial name
- COAPT (NCT01626079)
- Testing
- MitraClip System
- Where
- 86 sites in United States, Canada
- Volunteers
- 776 people
- Sponsor
- Abbott Medical Devices
Degenerative Disc Disease
Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects
The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel results to XLIF® single or multilevel results relative to the safety endpoints.
- Trial name
- NCT01878149
- Where
- 4 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Baxano Surgical, Inc.
Pain, Pain Management
Effective Screening for Pain Study
In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health…
- Trial name
- ESP (NCT01816763)
- Testing
- NRS pain one week, PEG, DVPRS
- Where
- 3 sites in United States
- Volunteers
- 569 people
- Sponsor
- VA Office of Research and Development