Clinical trials: Performance and Safety
Syringe
Evaluation of the Safety & Performance of 2 Intradermal Safety Devices
Several vaccinations are administered by the intradermal (ID) method where the vaccine is injected between layers of skin. The current technique required to do this can be difficult to learn and perform accurately, is slower to…
- Trial name
- NCT02556047
- Testing
- Star Intradermal Safety Device
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Surrey
Ostomy
Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™
The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.
- Trial name
- NCT01261988
- Testing
- VIPER, Esteem™ Cut to Fit One Piece Closed End Pouch
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ConvaTec Inc.
Nasolabial Fold, Safety
A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds. There is an 18 months follow up period.
- Trial name
- NCT03300466
- Testing
- GP0045, Comparator
- Where
- Sweden
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Healthy Subjects, Rheumatoid Arthritis
Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis
This study evaluates safety, tolerability, biodistribution and performance of the [68Ga]Ga-DOTA-Siglec-9 following a single intravenous administration in patients with active rheumatoid arthritis, vasculitis or pulmonary…
- Conditions
- Healthy Subjects, Rheumatoid Arthritis, Vasculitis, Pulmonary Sarcoidosis
- Trial name
- SIGLEC (NCT03755245)
- Testing
- [68Ga]Ga-DOTA-Siglec-9
- Where
- Finland
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Turku University Hospital
Spinal Cord Injuries
Beta-alanine Supplementation and Its Effects on Performance, Muscle Carnosine Content and Safety in Athletes With Spinal-cord Injury
Paralympians competing in wheelchair sports may experience a very high glycolytic demand (and therefore acidotic environment) in their upper-body muscles, particularly in high-intensity disciplines.
- Trial name
- NCT02604927
- Testing
- Beta-alanine, Dextrose
- Where
- Brazil
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Acne Scars
Clinical Evaluation of Fractional Radiofrequency for the Treatment Acne Scarring
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring.
- Trial name
- NCT03821324
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD)
A Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection
A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using [18F]Fluorbetazine…
- Trial name
- NCT07764679
- Testing
- [18F]Fluorbetazine injection
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- HTA Co., Ltd.
Caffeine, Exercise Performance
Energy Drink Effects on Performance, Mood, and Cardiovascular Outcomes
Energy drinks are widely promoted to increase energy, enhance mental alertness, and improve physical performance. ccording to the National Center for Complementary and Integrative Health (NCCIH) at NIH [1], next to multivitamins…
- Conditions
- Caffeine, Exercise Performance, Energy Drink, Cardiovascular Safety
- Trial name
- NCT05559372
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Nathaniel Jenkins
Cognitive Performance, Mood
Cognitive Performance and Mood After Ingestion of Dietary Supplement by University Students
This study investigates the effect of dietary supplementation on cognitive Performance and mood in university students over a 60-day period using a double-blind randomized controlled design.
- Conditions
- Cognitive Performance, Mood, Dietary Supplement, Safety
- Trial name
- NCT07438236
- Testing
- Dietary Supplement
- Where
- Portugal
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Cooperativa de Ensino Superior, Politécnico e Universitário
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
Healthy
Clinical Performance of All-in-One Light Multi-purpose for Silicone Hydrogel Contact Lenses
A clinical trial was conducted to assess the safety and acceptability of the Sauflon Multipurpose Solution when used with four different silicone hydrogel contact lens brands and one conventional hydrogel control lens was…
- Trial name
- NCT01392937
- Testing
- All-in-One Light multipurpose, Aquify care
- Where
- United Kingdom
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- Sauflon Pharmaceuticals Ltd
Angioplasty, Balloon, Disease, Peripheral Artery
Post-market Registry to Assess the Clinical Performance and Safety of the Passeo-18 Lux in Infrainguinal Arteries
The purpose of his study is to collect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the…
- Trial name
- NCT05175703
- Testing
- Passeo-18 Lux Paclitaxel releasing Balloon Catheter
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ajou University School of Medicine
Adverse Events
Effectiveness of a Proficiency-based Progression Communication Training Programme
Breakdown in communication between healthcare workers leads to significant patient harm on a daily basis, worldwide. The "safety huddle" is being introduced internationally as a means of overcoming this problem.
- Trial name
- PROTECT (NCT05390125)
- Testing
- A team, proficiency based progression, simulation training programme
- Where
- 2 sites in Ireland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Dorothy Breen
Breast Augmentation, Breast Reconstruction
Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
- Trial name
- EMMIE (NCT03386682)
- Testing
- ESTYME® MATRIX Breast Implants
- Where
- 8 sites in France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Symatese Aesthetics
Gastrointestinal Cancer
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.
- Trial name
- NCT06588881
- Testing
- nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
- Where
- Italy
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GEM SRL
Vital Signs
A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application
This study validates Lifelight® First, a software application, in a laboratory setting. Participants will undergo testing to obtain measurements from one or more of the four vital signs.
- Trial name
- NCT03998098
- Testing
- Oxygen Saturation (Oximetry), Heart Rate (Pulse), Respiratory Rate
- Where
- United Kingdom
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Xim Limited
Wrinkles Such as Nasolabial Folds
Post Market Study of Safety and Performance of RefillHA Volume+ for Facial Soft Tissue Augmentation and Correction of Wrinkles and Folds
This post market study was designed to collect clinical data regarding the safety and performance of RefillHA Volume+ upon its launch, from patients treated with the product in a routine clinical setting of treatments.
- Trial name
- NCT07109635
- Where
- Israel
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Glyance
Wounds
A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
In the course of this clinical trial, it was shown that the use of Granudacyn/VERIFORTE med wound irrigation solution in the course of adjuvant therapy supports wound healing through mechanical irrigation and moistening of the…
- Trial name
- NCT06083740
- Testing
- Granudacyn/Veriforte
- Where
- Austria
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- P.G.F. Industry Solutions GmbH
Muscle Strength
Investigation of the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance After the Initiation of a Resistance Training Program
The objective of this randomized, triple-blind, comparator controlled, parallel clinical trial is to investigate the functional equivalence of three test products compared to whey protein on muscular performance in a healthy…
- Trial name
- NCT04814225
- Testing
- Test Product 1, Test Product 2, Test Product 3
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Roquette Canada, LTD.
Moderate to Severe Nasolabial Fold
Safety and Performance of PTMC Dermal Filler
The goal of this clinical trial is to assess the safety and performance of the PTMC Dermal filler for treating moderate to severe nasolabial folds in adult men and women.
- Trial name
- NCT06316479
- Testing
- PTMC Dermal Filler
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Aqpha Medical B.V.