Clinical trials: Performance Assessment
Fertility Disorders, Infertility
Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction
This is a retrospective, observational, single-arm, multi-center study to evaluate the predictive performance of MAGENTA BLAST, an artificial intelligence (AI)-enabled software application, when used as analytical, adjunctive…
- Trial name
- NCT07464275
- Testing
- MAGENTA Blast
- Where
- Canada
- Volunteers
- 76 people
- Sponsor
- Future Fertility Inc.
COVID-19, Influenza A
Performance Evaluation of LumiraDx SARS-CoV-2, Flu A/B, and RSV Tests for COVID-19 Assessment
A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 \& FLU A/B Test, and LumiraDx SARS-CoV-2 \& RSV Test at Point of Care Testing Sites.
- Conditions
- COVID-19, Influenza A, Influenza Type B, RSV Infection
- Trial name
- INSPIRE-2 (NCT05268939)
- Testing
- LumiraDx SARS-CoV-2 & Flu A/B test, LumiraDx SARS-CoV-2 & RSV test
- Where
- 8 sites in United States
- Volunteers
- 589 people
- Sponsor
- LumiraDx UK Limited
Atrial Fibrillation
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation
This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF…
- Trial name
- DualSmart (NCT07845682)
- Testing
- Radiofrequency/Pulsed Field Ablation
- Volunteers
- 150 people
- Sponsor
- Biosense Webster, Inc.
Cataract
Evaluation of Performance of New IFIS Sleeve
A silicone sleeve will be used on the hydrodissection needle to avoid that the iris can prolaps through the gap between needle and incision wound.
- Trial name
- NCT06067360
- Testing
- IFIS sleeve
- Volunteers
- 20 people
- Sponsor
- Medicel AG
Healthy
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal…
- Trial name
- NCT01888497
- Testing
- Gabapentin, Diphenhydramine citrate, Triazolam
- Where
- 4 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Social Anxiety Disorder
A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder
This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to…
- Trial name
- NCT06809179
- Testing
- Fasedienol Nasal Spray - Fasedienol Nasal Spray
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- VistaGen Therapeutics, Inc.
Tendon Injuries
Adaprev in Digital Flexor Tendon Repair
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function…
- Trial name
- NCT01014494
- Testing
- Adaprev
- Where
- 9 sites in United Kingdom
- Volunteers
- 44 people
- Sponsor
- Renovo
Non-Small Cell Lung Cancer (NSCLC)
A Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.
The current research is a non-interventional (NIS) study seeking to support objective Performance Status (PS) assessments in the particular context of metastatic NSCLC adult patients. To do so, the study comprises two phases.
- Trial name
- Lupa-01 (NCT04751162)
- Testing
- Actigraphy device (wearable) and mobile application
- Where
- 10 sites in Spain
- Volunteers
- 71 people
- Sponsor
- Hoffmann-La Roche
Tachyarrhythmias
SecuraTM ICD Clinical Evaluation Study
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
- Trial name
- NCT00526227
- Testing
- Secura ICD
- Where
- 13 sites in Austria, Finland and 5 more
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Breast Cancer Surgery
Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment
The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment.
- Trial name
- MOBIBRA (NCT06303154)
- Testing
- Mobiderm Intimate Bra group
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Thuasne
Liver Preservation
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.
- Trial name
- REVIVE (NCT02449694)
- Testing
- OCS Liver
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- TransMedics
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
Peripheral Artery Disease, Peripheral Arterial Occlusive Disease
The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.
The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels.
- Trial name
- NCT05616169
- Testing
- Easy Flype/EasyHiFlype
- Where
- 2 sites in Italy
- Volunteers
- 52 people
- Sponsor
- CID S.p.A.
Skin Wounds, Abrasion
A Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions
Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions
- Trial name
- Dexpanthenol (NCT07642973)
- Testing
- hydrogel plaster with dexpanthenol, Standard plaster
- Where
- Italy
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Wooshin Labottach Co., Ltd.
Urinary Retention, Neurogenic Bladder
Connected Catheter- Safety and Effectiveness Study
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization.
- Conditions
- Urinary Retention, Neurogenic Bladder, Urologic Diseases
- Trial name
- NCT03843073
- Testing
- Connected Urinary Catheter
- Where
- 9 sites in United States
- Volunteers
- 9 people
- Sponsor
- Spinal Singularity
Hemorrhage, Blood Loss
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous…
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Trial name
- i-TRANSEP (NCT04588350)
- Testing
- i-SEP autotransfusion system
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- i-SEP
Osteoarthritis
A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System
The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion…
- Trial name
- NCT00761410
- Testing
- P.F.C. Sigma RP-F Total Knee Replacement
- Where
- 8 sites in India, Japan and 5 more
- Volunteers
- 170 people
- Sponsor
- DePuy International
Blood Routine Examination
Performance Evaluation of In-Vitro Diagnostic Device
This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four skyla Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical Chemistry Analyzer.
- Trial name
- NCT02894762
- Where
- Taiwan
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Lite-On Technology Corporation H.S.P.B
Atrial Fibrillation
Safety and Performance Study to Evaluate Access to Pulmonary Veins for Treatment of Paroxysmal AF
The study is intended to assess the safety and performance of the Vado™ Steerable Sheath in facilitating ease of access to the pulmonary veins (PV) for the treatment of paroxysmal atrial fibrillation and persistent atrial…
- Trial name
- NCT02521896
- Testing
- Steerable Sheath System
- Volunteers
- 8 people
- Sponsor
- Kalila Medical
COVID-19
Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test
Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method
- Trial name
- ASPIRE-2 (NCT05506618)
- Testing
- Nasal Swab, Nasopharyngeal swab
- Where
- 6 sites in United States
- Volunteers
- 758 people, healthy volunteers welcome
- Sponsor
- LumiraDx UK Limited