Clinical trials: Access and Evaluation
Mental Disorders
Reducing Stigma Among Healthcare Providers to Improve Mental Health Services
A growing number of trials have demonstrated treatment effectiveness for people with mental illness (PWMI) by non-specialist providers, such as primary care and community health workers, in low-resource settings.
- Trial name
- RESHAPE-mh (NCT02793271)
- Testing
- RESHAPE, PRIME/mhGAP
- Where
- Nepal
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Brandon A Kohrt, MD, PhD
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
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
End-stage Renal Disease
Propaten Randomized Investigation on Cost-benefit and Efficacy
The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.
- Trial name
- PRICE (NCT01601873)
- Testing
- PROPATEN, Standard Graft
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- The University of Texas Health Science Center, Houston
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
Surgical Wound
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures…
- Trial name
- NCT03573206
- Testing
- Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Cardiva Medical, Inc.
End-Stage Renal Disease
Cook Enforcer Post-Market Study
The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional…
- Trial name
- NCT03552289
- Testing
- Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, Conventional angioplasty balloon catheters
- Where
- 5 sites in United States
- Volunteers
- 211 people
- Sponsor
- Cook Research Incorporated
Arteriovenous Graft
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease.
- Trial name
- NCT01806584
- Testing
- SRM003, Participating Site's standard practice
- Where
- 46 sites in United States
- Volunteers
- 32 people
- Sponsor
- Shire
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
Quadriplegia, Spinal Cord Injury
Evaluation of a Tongue Operated Assistive Technology for Individuals With Severe Paralysis
This study was intended to evaluate a new assistive neuro-technology, known as the Tongue Drive System (TDS), by its potential end-users, i.e.
- Conditions
- Quadriplegia, Spinal Cord Injury, ALS
- Trial name
- TDS-1 (NCT01124292)
- Testing
- Tongue Piercing, Usability assessment
- Where
- 4 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Georgia Institute of Technology
AV Fistula
Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access
The Objectives of this study are: 1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo. 2.
- Trial name
- NCT02475837
- Testing
- Vorapaxar sulfate
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Ken Mahaffey
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
Liver Transplant
OCS Liver PROTECT Continued Access Protocol
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
- Trial name
- NCT04186221
- Testing
- OCS Liver System
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- TransMedics
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
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
End Stage Kidney Disease, Chronic Kidney Diseases
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in…
- Conditions
- End Stage Kidney Disease, Chronic Kidney Diseases, Kidney Failure, Kidney Insufficiency
- Trial name
- WAVE-Global (NCT04626427)
- Testing
- WavelinQ™ EndoAVF System
- Where
- 3 sites in Belgium, Greece and 1 more
- Volunteers
- 21 people
- Sponsor
- C. R. Bard
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
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.
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
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