Clinical trials: Performance and Safety
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
Safety and Performance of Motiva® Sizers
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Safety and Performance of the Nellix Endovascular Sealing System
Nellix® Registry Study: EVAS-Global
This registry has been designed as a multicenter, single arm, open label, post-market registry study with consecutive, eligible patient enrollment at each site.
- Trial name
- EVAS-FORWARD 1 (NCT02018744)
- Where
- 19 sites in Germany, Latvia and 6 more
- Volunteers
- 300 people
- Sponsor
- Endologix
Breast Implant; Complications, Quality of Life
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction, Safety and Performance
- Trial name
- STEPS S (NCT05345821)
- Where
- Brazil
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
Safety and Performance, Breast Tissue Expander
Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction
The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction.
- Trial name
- STEPS-R (NCT06981481)
- Testing
- Breast tissue expander
- Where
- 3 sites in Brazil
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
Tolerability of NT-301 Nasal Spray, Pharmacokinetics of NT-301 Nasal Spray
Clinical Trial of Intranasal Delivery of NT-301
The purpose of this research project is to investigate the safety and tolerability of an approved drug (Apomorphine) when administered as a nasal powder spray formulation (NT-301) as well as collect information on how NT-301…
- Conditions
- Tolerability of NT-301 Nasal Spray, Pharmacokinetics of NT-301 Nasal Spray, Safety of NT-301 Nasal Spray, Performance of NT-301 Nasal Spray Device
- Trial name
- APPROVE (NCT06954428)
- Testing
- NT-301 1 mg, NT-301 2 mg
- Where
- 2 sites in Australia
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Nano PharmaSolutions Australia
Exercise, Blood Pressure
Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance
Examining the safety and tolerability of Lentil Protein Hydrolysate in healthy males and females whilst exploring the effects of a dose range on blood pressure control and vascular function and exercise performance
- Conditions
- Exercise, Blood Pressure, Vasodilation, Vascular Function in Healthy Volunteers
- Trial name
- NCT06894875
- Testing
- Lentil protein hydrolysate
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Nuritas Ltd
Safety of the CytaCoat Foley Catheter, Performance of the CytaCoat Foley Catheter
Assessing Safety and Performance of the Novel CytaCoat Foley Catheter
This study is a prospective, single-center, single-blind, randomized, parallel assignment, controlled study to evaluate the safety and performance of the novel CytaCoat Foley catheter when compared to a Sterimed uncoated Foley…
- Trial name
- CYTA-FOL-2 (NCT07070921)
- Testing
- Foley catheter
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- CytaCoat AB
Performance and Safety
Clinical Study of CT 5400 RT for System Validation
The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.
- Trial name
- NCT06466577
- Testing
- CT 5400 RT System
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
The Performance / Safety of the Celsite® Venous Access Ports
The Performance / Safety of the Celsite® Venous Access Ports
The Celsite® Venous Access Ports System are intended to be used for repeated intravenous administration of, for example, chemotherapy, antibiotic and antiviral drugs, total parenteral nutrition, blood sampling or transfusion.
- Trial name
- CAP (NCT05572112)
- Testing
- Venous access port implantation
- Volunteers
- 500 people
- Sponsor
- B.Braun Médical - CoE Chasseneuil
Safety and Performance of Dressing Adhesive on Healthy Volunteers
A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing
AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone adhesive border.
- Trial name
- NCT01897285
- Testing
- AQUACEL® foam adhesive dressing
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ConvaTec Inc.