Clinical trials: Performance and Safety
- Condition Performance and Safety
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
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.
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
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.
Coronary Artery Disease
Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions
1.) Indigenously developed and designed BioMimeTM is a predictably safe \& efficacious 3rd generation drug eluting stent (DES) with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut…
- Trial name
- meriT-1 (NCT01507519)
- Testing
- Sirolimus Eluting Coronary Stent System (Biomime)
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Skin Transplantation
Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®)
FibDex® 2-2022 is a sponsored, post-marketing clinical follow-up (PMCF) study to monitor the clinical performance and safety of the CE marked product nanofibrillar cellulose (NFC) wound dressing, FibDex®, when used according to…
- Trial name
- NCT05666999
- Testing
- FibDex®, Suprathel, Aquacel Foam
- Where
- Finland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- UPM-Kymmene Corporation
Diaper Rash
Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash
Result of immaturity of the skin and factors promoting maceration and mechanical interactions, Irritant diaper dermatitis (IDD) can manifest as early as the third week of life.
- Trial name
- NCT03640897
- Testing
- Liniderm, Wipes, Water
- Where
- Poland
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Laboratoires Gilbert
To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
- Trial name
- NCT02036177
- Testing
- SCu300A IUB intrauterine device, T380A IUD
- Where
- 2 sites in Bulgaria, Romania
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
Healthy
Study to Compare the Effect of a Combination of Dipyridamole With Sustained Release and Acetyl Salicylic Acid (Aggrenox®) on the Performance Relevant to Safety and on the General Condition of Healthy Volunteers
Study to investigate whether psychomotor performance which is necessary for safety driving a car or operating machinery and safely participating in daily life is changed by Aggrenox®.
- Trial name
- NCT02278302
- Testing
- Aggrenox®, Ethanol
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Endodontic Treatment
A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material.
The goal of this study is prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material. The main question sit answers is 1.
- Trial name
- NCT06312085
- Testing
- Endofill
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Lumendo AG