Clinical trials: Physical Performance
Sarcopenia, Gait Disorders in Old Age
A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)
The main objective of the study is to evaluate the effect of two daily doses of BIO101 versus placebo on mobility function as measured by gait speed using the 400MW test.
- Conditions
- Sarcopenia, Gait Disorders in Old Age, Muscle Weakness
- Trial name
- SARA-INT (NCT03452488)
- Testing
- BIO101
- Where
- 22 sites in United States, Belgium
- Volunteers
- 233 people
- Sponsor
- Biophytis
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from asymptomatic women undergoing screening mammography.
- Conditions
- Breast Cancer, Tumors, Breast, Cancer Screening
- Trial name
- ADAPT (NCT02306265)
- Testing
- FFDM, DBT
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- GE Healthcare
Refractive Errors, Myopia
Performance Assessment of a Modified Daily Disposable Contact Lens
The purpose of this study is to compare visual acuity between two daily disposable contact lenses.
- Conditions
- Refractive Errors, Myopia, Hyperopia
- Trial name
- NCT03762668
- Testing
- Modified delefilcon A contact lenses, Delefilcon A contact lenses
- Where
- 5 sites in United States
- Volunteers
- 62 people
- Sponsor
- Alcon Research
HIV
Condom Performance in a Longitudinal Enhanced Assessment of User Experiences
This study will enroll 252 men who have sex with men (MSM) and 252 men who have sex with women (MSW) in a double-blind, three-way randomized crossover trial with conditions of fitted, thin, and standard condoms.
- Trial name
- C-PLEASURE (NCT02753842)
- Testing
- 5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms
- Volunteers
- 504 people, healthy volunteers welcome
- Sponsor
- Global Protection Corp.
Mitral Valve Regurgitation, Mitral Regurgitation
MitraClip EXPAND G4 Study
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
- Trial name
- NCT04177394
- Testing
- MitraClip G4 System
- Where
- 63 sites in United States, Canada and 8 more
- Volunteers
- 1,164 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease (CAD), Ischemic Heart Disease
A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes
This was a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in participants referred for evaluation of known coronary artery disease (CAD) or for suspected CAD with intermediate to high…
- Trial name
- NCT04594941
- Testing
- Flurpiridaz (18F) Injection
- Where
- 5 sites in United States
- Volunteers
- 38 people
- Sponsor
- GE Healthcare
Presbyopia, Refractive Error
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.
- Trial name
- NCT02235831
- Testing
- Nelfilcon A MF contact lenses (DACP MF), Nelfilcon A single vision contact lenses (DACP)
- Volunteers
- 24 people
- Sponsor
- Alcon Research
Cataract Extraction, Corneal Astigmatism
Assessment of Visual Performance in Patients With Low Levels of Astigmatism
To assess visual performance in patients with low levels (0.5-0.75 Diopters) of corneal astigmatism.
- Trial name
- NCT00842231
- Testing
- Visual performance measures
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alcon Research
Mitral Regurgitation
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
- Trial name
- ASCEND (NCT04382612)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 10 sites in Austria, Germany and 2 more
- Volunteers
- 42 people
- Sponsor
- Edwards Lifesciences
Single Ventricle Heart Disease
Fontan Udenafil Exercise Longitudinal Assessment Trial
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent subjects who have undergone the Fontan…
- Trial name
- FUEL (NCT02741115)
- Testing
- Udenafil
- Where
- 30 sites in United States, Canada and 1 more
- Volunteers
- 400 people
- Sponsor
- Mezzion Pharma Co. Ltd
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology…
- Trial name
- ADAPT-ENRICH (NCT02540083)
- Testing
- DBT and FFDM
- Where
- 2 sites in United States
- Volunteers
- 94 people
- Sponsor
- GE Healthcare
Obstructive Sleep Apnea
Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.
Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask.
- Trial name
- NCT02121912
- Testing
- FPH Pilairo Q CPAP mask, Any other market released nasal or nasal-pillow CPAP mask
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Fisher and Paykel Healthcare
Atrial Fibrillation, Atrial Flutter
Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
- Conditions
- Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
- Trial name
- NCT04211441
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- 2 sites in Czechia
- Volunteers
- 74 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Glaucoma
Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with…
- Trial name
- NCT03868254
- Testing
- XEN Group, Phacoemulsification
- Where
- United States
- Volunteers
- 174 people
- Sponsor
- Allergan
Small/Large Bowel
PillCam SB3 Capsule- Feasibility Study
Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation…
- Trial name
- NCT01433042
- Testing
- capsule endoscopy
- Where
- 4 sites in Israel, Romania and 2 more
- Volunteers
- 225 people
- Sponsor
- Medtronic - MITG
Anemia, Chronic Kidney Disease
LEARN-6™: A Prospective, Observational Nursing Home Study
This is a prospective, multicenter, observational, hypothesis-generating study exploring mobility, Quality of Life and other physical performance measures among older, long-term stay Nursing Home residents with CKD, with versus…
- Trial name
- NCT00727571
- Testing
- Observations
- Volunteers
- 815 people, healthy volunteers welcome
- Sponsor
- Amgen
Astigmatism
Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism
The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).
- Trial name
- NCT02071771
- Testing
- Nelfilcon A toric contact lenses, Etafilcon A toric contact lenses
- Volunteers
- 80 people
- Sponsor
- Alcon Research
Hip Arthropathy
Assessment of the Safety and the Performance of the SAGITTA EVL R Stems in Hip Arthroplasties
Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures.
- Trial name
- NCT05153473
- Testing
- Total Hip Arthroplasty Revision
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
Keratoconus
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
- Trial name
- NCT02979054
- Testing
- T4020
- Where
- 4 sites in Bulgaria, France and 2 more
- Volunteers
- 157 people
- Sponsor
- Laboratoires Thea
Nephrectomy, Prostatectomy
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
The purpose of this clinical investigation was to evaluate the safety and performance of the Bitrack System and its corresponding ElectroSurgical Endoscopic (ESE) instruments and Non-ElectroSurgical Endoscopic (NESE) instruments…
- Trial name
- NCT06119568
- Testing
- Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Rob Surgical Systems S.L.