C Scope Visualization System Prospective Study

Study Overview
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Brief Summary
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Evaluation of the performance and safety of the C Scope Visualization System

Detailed Description
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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.

Official Title
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Performance and Safety of the C Scope Visualization System in Arthroscopic Procedures - A Prospective Study

Conditions
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Knee Injuries and Disorders, Shoulder Disease, Shoulder Injuries

Intervention / Treatment
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* Device: C Scope Visualization System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Evaluation of the performance and safety of the C Scope Visualization System in the illumination and visualization of joints during diagnostic procedures
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm C-Scope Visualization System<br>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. | Device: C Scope Visualization System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician-rated procedural (diagnostic only) illumination and visualization with the C-Scope Visualization System | 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: | Peri procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician-rated confidence of diagnosis with the C-Scope Visualization System | Physician-rated confidence of diagnosis following needle arthroscopy attributed to visualization performance of the device using a 5-point scale | Peri procedure | 
| Physician-rated needle arthroscopy procedural ease with the C-Scope Visualization System | Physician-rated needle arthroscopy procedural ease using a 5- point scale | Peri procedure | 
| Procedure time with the C-Scope Visualization System | Procedure time (from start of arthroscopy to end of procedure) | Peri procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visualization, Illumination, Arthroscopic Procedures