Clinical trials: Device Performance
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test
The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.
- Trial name
- NCT02372071
- Testing
- BiliCare
- Where
- Israel
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Gerium Medical
Infertility
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial…
- Trial name
- ENDOMEDE (NCT03387059)
- Testing
- Forielle
- Where
- 7 sites in Italy
- Volunteers
- 9 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Wounds
Simplified Negative Pressure Wound Therapy
The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting.
- Trial name
- NCT01339429
- Testing
- simplified negative pressure wound therapy device (Wound Pump device)
- Where
- 2 sites in Rwanda
- Volunteers
- 41 people
- Sponsor
- Brigham and Women's Hospital
Healthy Volunteers, Adolescent
PureWick™ Adolescent Study
A prospective, uncontrolled, open-label healthy volunteer study to assess the performance of the PureWick Male and PureWick Flex Female external catheter devices in adolescents
- Trial name
- NCT06631313
- Testing
- PureWick System
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Burns
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review.
- Trial name
- NCT03333941
- Testing
- ReCell® Autologous Cell Harvesting Device
- Where
- 6 sites in United States
- Volunteers
- 76 people
- Sponsor
- Avita Medical
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Transcutaneous Bilirubinometry in Neonates With Bilicare System
The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.
- Trial name
- NCT02372058
- Testing
- BiliCare
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Gerium Medical
Distal Radius Fracture, Distal Ulna Fracture
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates.
- Conditions
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- Trial name
- NCT04653051
- Where
- United Kingdom
- Volunteers
- 111 people
- Sponsor
- Zimmer Biomet
Diabetes Mellitus
Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report
The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used…
- Trial name
- NCT02910674
- Testing
- Dario Blood Glucose Monitoring System
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- LabStyle Innovations Ltd.
Thromboembolic Events
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States…
- Trial name
- NCT02052544
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 123 people
- Sponsor
- dsm-firmenich Switzerland AG
Diabetes Mellitus
CareLink Connect - Technical Evaluation Study
The purpose of this study is to evaluate the performance, patient satisfaction and safety of connectivity gateway device CareLink Connect, transferring CGM (Continuous Glucose Monitoring) data from a VEO insulin pump to CareLink…
- Trial name
- NCT01989975
- Where
- 2 sites in Denmark, Netherlands
- Volunteers
- 40 people
- Sponsor
- Medtronic MiniMed, Inc.