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)
Oncoplastic Breast Surgery, Bilateral Surgery
A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients
The purpose of the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the same time, and the purpose of…
- Trial name
- PICO7Y (NCT03835845)
- Testing
- PICO7Y
- Where
- 5 sites in Netherlands, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Abdominal Aortic Aneurysms
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable…
- Trial name
- NCT01328197
- Testing
- Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Bolton Medical
Mitral Valve Insufficiency
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation…
- Trial name
- NCT04343313
- Testing
- Half Moon TMVr System
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Half Moon Medical
Hemodialysis Access Failure
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
- Trial name
- NCT03734679
- Testing
- SurVeil Drug Coated Balloon
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 12 people
- Sponsor
- SurModics, Inc.
Colorectal Cancer Screening
Performance Study of the Invendo C20 Colonoscope System in Colorectal Cancer Screening
The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the Invendo C20 Colonoscopy System
- Trial name
- NCT01054924
- Where
- 2 sites in Germany
- Volunteers
- healthy volunteers welcome
- Sponsor
- Invendo Medical GmbH
Breast Augmentation, Breast Reconstruction
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
The aim of this observational, Post-market, Retro-prospective, open, non-randomized, non-comparative, multicentric, European study is to evaluate the safety and performance of the Monobloc® - Silicone SoftOne® breast implants at…
- Trial name
- SOFTONE (NCT07904091)
- Testing
- Breast augmentation, Breast reconstruction
- Where
- 5 sites in France
- Volunteers
- 630 people
- Sponsor
- Laboratoires ARION
Osteoarthritis, Arthritis
A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup
This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.
- Conditions
- Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head
- Trial name
- NCT02196818
- Testing
- Mpact Acetabular Shell
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Left Ventricular Dysfunction, Heart Failure
Detection of Heart Conditions Using Artificial Intelligence
The purpose of this study is to evaluate how Eko AI performs in the real world, front-line setting where the availability of sophisticated, expensive diagnostic tools is limited, and where there is a premium on detecting VHD…
- Trial name
- NCT04933890
- Testing
- Use of Eko DUO electronic stethoscope
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Eko Devices, Inc.
Abdominal Aortic Aneurysm, Endoleak
ANEUFIX for Endoleak Type II Repair
The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR…
- Trial name
- NCT03918460
- Testing
- ANEUFIX
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 40 people
- Sponsor
- TripleMed B.V.
Dry Eye, Dry Eye Disease
PMCF Study to Evaluate Performance and Safety of "Hyaluronic Acid (HA)-Based Eyedrops" Used to Relieve Dry Eye Symptoms
Dry eye disease (DED), also called keratoconjunctivitis sicca, is a common ocular condition characterized by a loss of homeostasis of the tear film and inflammation of the ocular surface.
- Conditions
- Dry Eye, Dry Eye Disease, Kerato Conjunctivitis Sicca
- Trial name
- NCT05807360
- Testing
- Hyaluronic acid eye drops
- Where
- Italy
- Volunteers
- 160 people
- Sponsor
- C.O.C. Farmaceutici S.r.l.
Abdominal Fat
VelaShape III Device in Comparison to Cryolipolysis for Circumferential Reduction
The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.
- Trial name
- NCT02143960
- Testing
- VelaShape III, CoolSculpt
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Syneron Medical
Colon Cancer, Rectal Cancer
Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients
A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.
- Trial name
- NCT00867724
- Testing
- Aer-O-Scope Colonoscopy
- Where
- Israel
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- GI View Ltd.
Active Tuberculosis, Latent Tuberculosis Infection
Performance Evaluation of the VIDAS TB-IGRA Assay.
This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection.
- Conditions
- Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
- Trial name
- NCT04048018
- Testing
- Blood draw and IGRA test
- Where
- 24 sites in United States, Brazil and 7 more
- Volunteers
- 2,401 people, healthy volunteers welcome
- Sponsor
- BioMérieux
Correction of Facial Wrinkles/Folds, Facial Volume Enhancement
Post-Market Clinical Follow-up Performance and Safety Study of Etermis 3 and 4 in the Face
To confirm the clinical performance of Etermis 3 and Etermis 4 based on the blinded investigator´s assessments on the respective Merz Aesthetics Scales from day 0 (D0) pre-injection to month 6/7 (depending on touch up) visit for…
- Trial name
- POMET (NCT04210258)
- Testing
- Etermis 3, Etermis 4
- Where
- 6 sites in Germany
- Volunteers
- 154 people
- Sponsor
- Merz Pharmaceuticals GmbH
Respiratory Failure
Multicenter, Multinational, Follow-Up Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
The study will be a multicenter, multinational, prospective single arm blinded non-interventional follow-up study (from DXT-CS-005) to validate RESPINOR DXT's performance to identify patients at increased risk of weaning failure…
- Trial name
- DE-RISK WF II (NCT05580185)
- Testing
- RESPINOR DXT
- Where
- 8 sites in France, Norway
- Volunteers
- 145 people
- Sponsor
- Respinor AS
Hernia, Ventral, Hernia, Hiatal
GORE® ENFORM Biomaterial Product Study
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair).
- Conditions
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
- Trial name
- ENF 18-06 (NCT04718168)
- Testing
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Where
- 9 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Cervical Disc Disease, Degenerative Disc Disease
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).
- Trial name
- NCT05258435
- Testing
- NuVasive Simplify Cervical Artificial Disc
- Where
- 10 sites in United States
- Volunteers
- 131 people
- Sponsor
- NuVasive
Primary Open Angle Glaucoma
Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma
It is an interventional study for the treatment of Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) system. This medical device includes a sclerectomy punch and injector assembly.
- Trial name
- NCT07358650
- Testing
- Hexiris Microinvasive Scleral Trephine (MIST)
- Where
- 5 sites in Canada
- Volunteers
- 25 people
- Sponsor
- Hexiris Inc
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
Acute Kidney Injury
Safety and Performance Evaluation of multiPlus Dialysate During CRRT
Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6 hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration [CVVHD(F)].
- Trial name
- multiPlus (NCT05315817)
- Testing
- multiPlus dialysate
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
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