Clinical trials: Clinical Performance
Aortic Dissection
Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection.
- Trial name
- NCT01114724
- Testing
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Where
- 17 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiovascular
Astigmatism
A Clinical Performance of Two Soft Toric Contact Lenses
The study objective was to gather short-term clinical performance data for two soft toric contact lenses.
- Trial name
- NCT05633082
- Testing
- Lens 1 (omafilcon B), Lens 2 (fanfilcon A)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- CooperVision, Inc.
Rhytides, Wrinkle
Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
- Trial name
- NCT03776461
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Graft vs Host Disease, Congenital Aniridia
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely.
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome
- Trial name
- NCT02945176
- Testing
- ARGOS-IO system
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Astigmatism
Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses
The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.
- Trial name
- NCT02248766
- Testing
- somofilcon A
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- CooperVision, Inc.
Ileostomy - Stoma, Colostomy
A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
- Trial name
- NCT02517541
- Testing
- SenSura Mio Convex Soft
- Where
- 9 sites in United States, Netherlands and 2 more
- Volunteers
- 74 people
- Sponsor
- Coloplast A/S
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
Tachyarrhythmias, Heart Failure
ConsultaTM CRT-D Clinical Evaluation Study
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00526162
- Testing
- Bi-ventricular Implantable Cardioverter Defibrillator
- Where
- Germany
- Volunteers
- 83 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Ametropia, Myopia
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses
The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.
- Conditions
- Ametropia, Myopia, Hyperopia, Astigmatism
- Trial name
- NCT05959200
- Testing
- Serafilcon A toric contact lenses, Senofilcon A toric contact lenses, CLEAR CARE
- Where
- 7 sites in United States
- Volunteers
- 92 people
- Sponsor
- Alcon Research
Refractive Ametropia
Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens
This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.
- Trial name
- NCT01484028
- Testing
- etafilcon A control lens (1DM), etafilcon A with print and PVP for light eyes (EALE), etafilcon A with print and PVP for dark eyes (EADE)
- Where
- 15 sites in United States
- Volunteers
- 275 people
- Sponsor
- Johnson & Johnson Vision Care, Inc.
Wrinkles, Rhytides
TriActive+ Radiofrequency (RF) for Non-Invasive Treatment of Wrinkles and Rhytides
The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source, the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple treatments.
- Trial name
- NCT01859611
- Testing
- TriActive+ RF
- Where
- 2 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- El. En. SpA
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
Visual Acuity
Clinical Performance Evaluation of Two Silicone Hydrogel Lenses
This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.
- Trial name
- NCT02756078
- Testing
- TEST Contact Lens, CONTROL Contact Lens
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Vision Care, Inc.
Partial Edentulism, Tooth Disease
A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases
This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design of the implant.
- Trial name
- RadioCity (NCT00723944)
- Testing
- Osseotite Certain Prevail, Osseotite Certain
- Where
- Germany
- Volunteers
- 102 people
- Sponsor
- ZimVie
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
Glaucoma
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg…
- Trial name
- NCT00772330
- Testing
- Glaucoma Drainage Device
- Where
- Dominican Republic
- Volunteers
- 23 people
- Sponsor
- InnFocus Inc.
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.
Burn Injury, Skin Graft
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn…
- Trial name
- MpTAg03 (NCT02210208)
- Testing
- Mepitel® Ag, Mepilex® Transfer Ag
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Molnlycke Health Care AB
HIV
Condom Performance in a Longitudinal Enhanced Assessment of User Experiences
This study will enroll 252 men who have sex with men (MSM) and 252 men who have sex with women (MSW) in a double-blind, three-way randomized crossover trial with conditions of fitted, thin, and standard condoms.
- Trial name
- C-PLEASURE (NCT02753842)
- Testing
- 5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms
- Volunteers
- 504 people, healthy volunteers welcome
- Sponsor
- Global Protection Corp.