Clinical trials: Clinical Performance
Bacterial Vaginosis
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3…
- Trial name
- NCT03762083
- Testing
- pHyph generation I
- Where
- 2 sites in Sweden
- Volunteers
- 24 people
- Sponsor
- Gedea Biotech AB
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Caries Pit and Fissure Limited to Enamel
Clinical Performance of Two Fissure Sealants
Comparison of the retention of a new fissure sealant (Helioseal F Plus) and a fissure sealant that has been on the market for years in children
- Trial name
- NCT03470129
- Testing
- fissure sealing
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Ivoclar Vivadent AG
Skin Resurfacing, Wrinkle Reduction
Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction
The purpose of this study is to determine whether the Matrix RF applicator is effective in the treatment of facial skin texture and wrinkle reduction.
- Trial name
- NCT00887913
- Testing
- Fractional RF treatment with Matrix RF applicator
- Where
- 3 sites in United States, Canada
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Syneron Medical
Healthy
Clinical Performance of Masimo Rad-GT
The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy of temperature measurements.
- Trial name
- NCT05779397
- Testing
- Masimo RAD-GT
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Deafness; Sensoneural Single Sided, Conductive Hearing Loss
Clinical Performance of a New Implant System for Bone Conduction Hearing
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
- Conditions
- Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
- Trial name
- NCT03086135
- Testing
- Osia System
- Where
- 5 sites in United States, Australia and 3 more
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Cochlear
Healthy
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal…
- Trial name
- NCT01888497
- Testing
- Gabapentin, Diphenhydramine citrate, Triazolam
- Where
- 4 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Tachyarrhythmias
SecuraTM ICD Clinical Evaluation Study
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
- Trial name
- NCT00526227
- Testing
- Secura ICD
- Where
- 13 sites in Austria, Finland and 5 more
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hearing Loss
Ponto Implantation Using a Minimally Invasive Surgical Technique
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands).
- Trial name
- NCT04606823
- Testing
- Minimally invasive surgery, Glasgow Benefit Inventory (GBI), Additional follow-up visits after surgery
- Where
- 7 sites in Denmark, Netherlands and 2 more
- Volunteers
- 52 people
- Sponsor
- Oticon Medical
Glaucoma, Open Angle Glaucoma
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
- Trial name
- NCT04773106
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 22 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Healthy
INVSENSOR00013 Respiratory Rate Clinical Performance Study
The objective of this prospective study is to compare the noninvasive respiration from pleth (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured by capnography (RRref), Masimo's RAM…
- Trial name
- NCT03440619
- Testing
- INVSENSOR00013
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Myopia, Safety Issues
The Safety and Effectiveness of Breath-O Lenses
In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression.
- Trial name
- NCT03616600
- Testing
- Breath-O-Correct Lens
- Where
- Hong Kong
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- The Hong Kong Polytechnic University
Rotator Cuff
Safety of Treatment of Shoulder Repair
This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair
- Trial name
- HEALICOIL_KNTL (NCT04552119)
- Testing
- HEALICOIL Knotless PEEK, HEALICOIL Knotless REGENESORB
- Where
- 5 sites in United States
- Volunteers
- 138 people
- Sponsor
- Smith & Nephew, Inc.
Non-valvular Atrial Fibrillation
WAVECREST Post Market Clinical Follow-Up (PMCF) Study
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in…
- Trial name
- NCT03204695
- Testing
- Percutaneous LAA Closure, Anticoagulation or Clopidogrel
- Where
- Belgium
- Volunteers
- 27 people
- Sponsor
- Coherex Medical
Glaucoma, Glaucoma, Open Angle
AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma
To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.
- Trial name
- NCT02036541
- Testing
- AqueSys XEN 45 Glaucoma Implant
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- AqueSys, Inc.
Fever, Healthy
Clinical Performance of Masimo INVSENSOR00048
The objective of this clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
- Trial name
- NCT06289556
- Testing
- Masimo INVSENSOR00048
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Dental Caries
Safety and Performance Evaluation of the Calcivis System
This is a prospective, multi-centre clinical study to evaluate the safety and performance of the Calcivis Caries Activity Imaging System.
- Trial name
- NCT02780856
- Testing
- Imaging with the Calcivis System
- Where
- 4 sites in United Kingdom
- Volunteers
- 110 people
- Sponsor
- Calcivis Ltd
Refractive Errors, Myopia
Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.
- Conditions
- Refractive Errors, Myopia, Hyperopia
- Trial name
- NCT04403542
- Testing
- Lehfilcon A contact lens, Comfilcon A contact lens
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Alcon Research
Hemorrhage, Surgical
Clinical Safety and Performance of GATT-Patch in Open Liver Surgery
The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.
- Trial name
- NCT04819945
- Testing
- GATT-Patch
- Where
- 3 sites in Netherlands
- Volunteers
- 56 people
- Sponsor
- GATT Technologies BV
Tooth Disease, Partial Edentulism
A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs
This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.
- Trial name
- CollegeBowl (NCT00726063)
- Testing
- Nanotite dental implant, Osseotite dental implant
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- ZimVie