Knee Injuries and Disorders, Shoulder Disease, Shoulder Injuries
Conditions
Keywords
Visualization, Illumination, Arthroscopic Procedures
Brief summary
Evaluation of the performance and safety of the C Scope Visualization System
Detailed description
The C Scope Visualization System Prospective Study is a post-market, single-arm, prospective, multicenter study conducted in the United States. The purpose of the study is to evaluate the performance and safety of the C Scope Visualization System in the illumination and visualization of joints from diagnostic procedure through 1-week and 1-month follow-up.
Interventions
DEVICEC Scope Visualization System
The C Scope Visualization System is indicated to be used by a trained physician to provide illumination and visualization in arthroscopic procedures of an interior cavity of the body through a surgical opening.
Sponsors
CIT Ortho
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Evaluation of the performance and safety of the C Scope Visualization System in the illumination and visualization of joints during diagnostic procedures
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is 18 years of age or older * Subject can fluently speak and read English * Subject is able to provide informed consent * Subject agrees to all protocol-required follow-ups * Subject meets the C Scope Indications for Use according to approved labeling
Exclusion criteria
* History of open surgery to the index joint resulting in scarring that might inhibit evaluation with the C Scope Visualization System * Suspected fracture of joint structures * Subject has any contraindications listed in the approved labeling including active infection * In the opinion of the investigator, it is not in the subject's best interest to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician-rated procedural (diagnostic only) illumination and visualization with the C-Scope Visualization System | Peri procedure | Physician-rated procedural (diagnostic only) illumination and visualization of the areas with the C-Scope Visualization System of the joint intended to be evaluated using a 5-point scale: |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician-rated confidence of diagnosis with the C-Scope Visualization System | Peri procedure | Physician-rated confidence of diagnosis following needle arthroscopy attributed to visualization performance of the device using a 5-point scale |
| Physician-rated needle arthroscopy procedural ease with the C-Scope Visualization System | Peri procedure | Physician-rated needle arthroscopy procedural ease using a 5- point scale |
| Procedure time with the C-Scope Visualization System | Peri procedure | Procedure time (from start of arthroscopy to end of procedure) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Adverse Events | 1 week and 1 month post procedure | Adverse events/serious adverse event rates related to the procedure or device |
Countries
United States
Outcome results
None listed