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Evaluation of the performance and safety of the C Scope Visualization System
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm C-Scope Visualization System | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C Scope Visualization System | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Adverse Events | Adverse events/serious adverse event rates related to the procedure or device | 1 week and 1 month post procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad M Hanson, MD | Desert Orthopaedic Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Orthopaedic Center | Henderson | Nevada | 89052 | United States |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D004194 | Disease |
| D000070599 | Shoulder Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Evaluation of the performance and safety of the C Scope Visualization System in the illumination and visualization of joints during diagnostic procedures
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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 |