C Scope Visualization System Prospective Study
Study Details
Study Description
Brief Summary
Evaluation of the performance and safety of the C Scope Visualization System
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm C-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. |
Device: C 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- Safety Adverse Events [1 week and 1 month post procedure]
Adverse events/serious adverse event rates related to the procedure or device
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is 18 years of age or older
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Subject can fluently speak and read English
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Subject is able to provide informed consent
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Subject agrees to all protocol-required follow-ups
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Subject meets the C Scope Indications for Use according to approved labeling
Exclusion Criteria:
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History of open surgery to the index joint resulting in scarring that might inhibit evaluation with the C Scope Visualization System
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Suspected fracture of joint structures
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Subject has any contraindications listed in the approved labeling including active infection
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In the opinion of the investigator, it is not in the subject's best interest to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Desert Orthopaedic Center | Henderson | Nevada | United States | 89052 |
Sponsors and Collaborators
- CIT Ortho
Investigators
- Principal Investigator: Chad M Hanson, MD, Desert Orthopaedic Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZSC-DVER-330-02-PR32