Clinical trials: Safety and Performance
Acne Scars
Clinical Evaluation of Fractional Radiofrequency for the Treatment of 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
- NCT03767153
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Ileostomy - Stoma
Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
- Trial name
- NCT01957488
- Testing
- Coloplast Test Product 1, Coloplast Test Product 2, Coloplast SenSura
- Where
- 4 sites in Denmark, Netherlands and 2 more
- Volunteers
- 183 people
- Sponsor
- Coloplast A/S
Keratoconus
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
- Trial name
- NCT02979054
- Testing
- T4020
- Where
- 4 sites in Bulgaria, France and 2 more
- Volunteers
- 157 people
- Sponsor
- Laboratoires Thea
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Interstitial Cystitis and Bladder Pain Syndrome
Real-world Evidence Study on Cystistat
This study will be conducted with the aim of ensuring the continued acceptability of the benefit-risk ratio and confirming the safety and performance of the device throughout its expected lifetime.
- Trial name
- IC/BPS (NCT05544695)
- Testing
- intravesical sodium hyaluronate (Cystistat®)
- Where
- Austria
- Volunteers
- 74 people
- Sponsor
- MEDA Pharma GmbH & Co. KG
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.
Mitral Valve Insufficiency
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.
- Trial name
- NCT02322840
- Testing
- Twelve TMVR Implant, Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
- Where
- 32 sites in United States, Australia and 5 more
- Volunteers
- 128 people
- Sponsor
- Medtronic Cardiovascular
Muscular Dystrophies, Muscular Dystrophy, Duchenne
A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy
HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne Muscular Dystrophy (DMD).
- Conditions
- Muscular Dystrophies, Muscular Dystrophy, Duchenne, Muscular Disorders, Atrophic, Muscular Diseases
- Trial name
- HOPE-2 (NCT03406780)
- Testing
- CAP-1002
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Capricor Inc.
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
Atrial Fibrillation, Atrial Flutter
Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
- Conditions
- Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
- Trial name
- NCT04211441
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- 2 sites in Czechia
- Volunteers
- 74 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Cholangiopancreatography, Endoscopic Retrograde
A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
The objective of the SAMISEN study phase B is to assess the performance and safety of diagnostic and therapeutic procedures with the Olympus Motorized Spiral Enteroscope (PowerSpiral) in subjects with surgically altered…
- Trial name
- SAMISEN-B (NCT05129449)
- Testing
- Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 89 people
- Sponsor
- Olympus Europe SE & Co. KG
Hip Arthropathy
Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF.
- Trial name
- 2022-09 (NCT06096155)
- Where
- France
- Volunteers
- 46 people
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
Healthy
Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer
The purpose of the study is to test the performance and safety of the Bioserenity pulse oxymeter EOXY. For that, and in agreement with ISO60601-2-61 norm and FDA regulation, measures of heart rate, with a gold-standard, and SaO2…
- Trial name
- EOXY (NCT03614416)
- Testing
- EOXY device, Gold standard oximeter, SaO2 sampling
- Where
- Belgium
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- BioSerenity
Carcinoma, Non-Small-Cell Lung
Phase II Safety and Tolerability Trial With Nab-Paclitaxel Plus Carboplatin Followed by Nab-Paclitaxel for First Line Treatment of NSCLC Subjects With ECOG PS 2
4 cycles of induction treatment with nab-paclitaxel and carboplatin followed by nab-paclitaxel monotherapy for those subjects who are progression free at the end of 4 cycles.
- Trial name
- AboundPS2 (NCT02289456)
- Testing
- nab-Paclitaxel, Carboplatin
- Where
- 8 sites in United States
- Volunteers
- 40 people
- Sponsor
- Celgene
Prostate Cancer
Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand…
- Trial name
- NCT04186819
- Testing
- rhPSMA-7.3 (18F) Injection, Positron Emission Tomography scan
- Where
- 34 sites in United States, Finland and 2 more
- Volunteers
- 356 people
- Sponsor
- Blue Earth Diagnostics
Partial Edentulism
Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism
A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants
- Trial name
- NCT03283241
- Testing
- Zolidd One ExHex, One ExHex
- Where
- 3 sites in Sweden
- Volunteers
- 62 people
- Sponsor
- Addbio AB
Peripheral Neuropathy
BlueWind Medical Reprieve System for the Treatment of PNP
The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.
- Trial name
- PNP (NCT02062398)
- Testing
- The Reprieve System
- Where
- 4 sites in Belgium, Poland
- Volunteers
- 13 people
- Sponsor
- BlueWind Medical
Pulmonary Arterial Hypertension
Nitric Oxide, GeNO Nitrosyl Delivery System
The primary aim of the study is to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during RHC.
- Trial name
- NCT01165047
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Wake Forest University Health Sciences
Acne Scars - Mixed Atrophic and Hypertrophic
Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of 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
- NCT04827680
- Testing
- Venus Viva MD
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Ileostomy - Stoma
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
- Trial name
- NCT01799239
- Testing
- Test product, SenSura
- Where
- Sweden
- Volunteers
- 32 people
- Sponsor
- Coloplast A/S