Clinical trials: Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Condition Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Funder type Industry (pharma, biotech, devices)
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
Pelvic Organ Prolapse (POP), Synthetic Mesh
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation.
- Conditions
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery
- Trial name
- ProGYNious (NCT07497321)
- Testing
- Surgical mesh for pelvic organ prolapse repair (ProGYNious)
- Where
- 4 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Retention, Urinary
Investigation of Non-CE Marked Intermittent Catheters for Females
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter.
- Trial name
- NCT04557787
- Testing
- SpeediCath® Standard female, New intermittent Variant 1 catheter for females, New intermittent Variant 2 catheter for females
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Coloplast A/S
Ischemic Stroke
Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study
Prospective, single-arm, open label, Safety and Performance clinical investigation.
- Trial name
- NCT02994563
- Testing
- Thrombectomy Device
- Where
- 4 sites in Spain, Sweden
- Volunteers
- 5 people
- Sponsor
- Amnis Therapeutics
Nasal Dryness
Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray
The purpose of this study is to see whether the nasal spray can help improve hydration of the nasal mucosa, reduce discomfort linked to nasal dryness, and confirm its safety in patients suffering from nasal dryness.
- Trial name
- NCT07204158
- Testing
- Spray pompe nasal confort
- Where
- France
- Sponsor
- YSLab
Glaucoma, Open-Angle, Ocular Hypertension
Performance of the Travoprost Intraocular Implant
To evaluate the performance of the Travoprost Intracameral Implant by determining residual drug in explanted implants of the Travoprost Intracameral Implant and by determining aqueous humor concentrations of travoprost free acid…
- Trial name
- NCT06582732
- Testing
- Travoprost Intracameral Implant exchanged at Month 12, Travoprost Intracameral Implant exchanged at Month 3, Travoprost Intracameral Implant exchanged at Month 6
- Where
- Armenia
- Volunteers
- 210 people
- Sponsor
- Glaukos Corporation
Cataract
Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
The objective of the study is to evaluate the safety and performance of the enVista trifocal intraocular lens when implanted in the capsular bag.
- Trial name
- NCT04224155
- Testing
- enVista MX60EFH trifocal intraocular lenses (IOLs), enVista MX60E monofocal intraocular lenses (IOLs)
- Where
- 9 sites in Canada
- Volunteers
- 165 people
- Sponsor
- Bausch & Lomb Incorporated
Vision, Binocular, Sports Medicine
The Effect of VOXX/eSmartr High Performance Technology on Sports Vision Ability
This study is designed to compare the effect of Voxx/eSmartr technology on common measures of sports vision performance including (Hand-Eye Coordination/Reaction time, visual concentration and basic visual functions of size…
- Trial name
- NCT04051138
- Testing
- Voxx socks and sleeves
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- ChampionsEdge, LLC
Venous Leg Ulcer
Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers
This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.
- Trial name
- NCT07211243
- Testing
- PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional), PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
- Where
- 9 sites in Poland
- Volunteers
- 150 people
- Sponsor
- Lohmann & Rauscher
Respiratory Rate Monitoring
Respiration From Pleth Validation
This observational clinical investigation evaluates the performance of respiratory rate derived from the plethysmography waveform (Respiration from Pleth, RfP) using Philips FAST Pulse Oximetry technology.
- Trial name
- RfP Validation (NCT07449715)
- Testing
- Physiological Monitoring with SpO₂ Sensors and Capnography
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 113 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Polyp, Colorectal
Colorectal Polyp Clinical Decision Support Device Study
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
- Conditions
- Polyp, Colorectal, Colonoscopy
- Trial name
- CDSD (NCT04437615)
- Testing
- Colonoscopy, Clinical Decision Support Device
- Where
- United States
- Volunteers
- 2,379 people
- Sponsor
- Olympus Corporation of the Americas
Acne Vulgaris, Folliculitis
Evaluation of Safety and Performance of Ialuxid Gel in Treatment of Acne Vulgaris, and Folliculitis
The Research Question of the present study is the following: in a population of men and women affected by acne vulgaris, and folliculitis, will Ialuxid® Gel (hydrogen peroxide, hyaluronic acid and glycine) improve the course of…
- Trial name
- NCT05345093
- Testing
- Ialuxid gel
- Where
- Romania
- Volunteers
- 66 people
- Sponsor
- BMG Pharma
Breast Implant; Complications, Quality of Life
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction, Safety and Performance
- Trial name
- STEPS S (NCT05345821)
- Where
- Brazil
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
Sensorineural Hearing Loss, Bilateral
Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy
Main objective: Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech Secondary objectives: Evaluate the time evolution…
- Trial name
- NCT03694704
- Testing
- FineHearing strategy
- Where
- France
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Bradycardia, Atrial Tachyarrhythmia
AdvisaTM IPG Clinical Evaluation Study
The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and clinical performance of the Advisa DR Implantable Pulse Generator (IPG).
- Trial name
- NCT00839384
- Testing
- Advisa IPG
- Where
- Czechia
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Critical Illness
A Open Study to Evaluate the Performance of Dressing on Subject With High Risk of Skin Breakdown
The rational for the study is to add a thin self-adherent dressing on critically ill patients. Evaluate if the dressing might protect the skin for further breakdown.Participants will be followed for the duration of hospital stay…
- Trial name
- NCT01354899
- Where
- Sweden
- Volunteers
- 24 people
- Sponsor
- Molnlycke Health Care AB
Healthy
Evaluate the Effects of Citicoline on Mood in Healthy Adults
The objective of this trial is to determine the effects of citicoline on mood in healthy Men and Women compared to a placebo.
- Trial name
- NCT07089238
- Testing
- Citicoline
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Kirin Holdings Company, Limited
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Austria Satellite Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- NCT01667016
- Where
- 8 sites in Austria
- Volunteers
- 305 people
- Sponsor
- Biotronik Vertriebs-GmbH
Diaper Rash
Multicenter, National, Observational, Prospective, Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
This study is being conducted to provide updated clinical data on safety and performance (demonstrated previously for CE marking under the Medical Devices Directive) Cooper Aqueous Eosin 2%.
- Trial name
- EA2 (NCT05599763)
- Where
- France
- Volunteers
- 67 people
- Sponsor
- Cooperation Pharmaceutique Francaise
Breast Cancer
CairnSurgical Breast Cancer Locator (BCL) Post-Market Study
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in…
- Trial name
- NCT06461663
- Testing
- Breast Cancer Locator Guided Breast Conserving Surgery
- Where
- 6 sites in Germany, Italy and 1 more
- Volunteers
- 35 people
- Sponsor
- CairnSurgical, Inc.
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