Back to resultsC Scope Visualization System Prospective Study
Primary Purpose
Knee Injuries and Disorders, Shoulder Disease, Shoulder Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
C Scope Visualization System
Sponsored by
About this trial
This is an interventional diagnostic trial for Knee Injuries and Disorders focused on measuring Visualization, Illumination, Arthroscopic Procedures
Eligibility Criteria
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
Sites / Locations
- Desert Orthopaedic CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm C-Scope Visualization System
Arm Description
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.
Outcomes
Primary Outcome Measures
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:
Secondary Outcome Measures
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
Physician-rated needle arthroscopy procedural ease with the C-Scope Visualization System
Physician-rated needle arthroscopy procedural ease using a 5- point scale
Procedure time with the C-Scope Visualization System
Procedure time (from start of arthroscopy to end of procedure)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05153863
Brief Title
C Scope Visualization System Prospective Study
Official Title
Performance and Safety of the C Scope Visualization System in Arthroscopic Procedures - A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIT Ortho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries and Disorders, Shoulder Disease, Shoulder Injuries
Keywords
Visualization, Illumination, Arthroscopic Procedures
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm C-Scope Visualization System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
C Scope Visualization System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physician-rated procedural (diagnostic only) illumination and visualization with the C-Scope Visualization System
Description
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:
Time Frame
Peri procedure
Secondary Outcome Measure Information:
Title
Physician-rated confidence of diagnosis with the C-Scope Visualization System
Description
Physician-rated confidence of diagnosis following needle arthroscopy attributed to visualization performance of the device using a 5-point scale
Time Frame
Peri procedure
Title
Physician-rated needle arthroscopy procedural ease with the C-Scope Visualization System
Description
Physician-rated needle arthroscopy procedural ease using a 5- point scale
Time Frame
Peri procedure
Title
Procedure time with the C-Scope Visualization System
Description
Procedure time (from start of arthroscopy to end of procedure)
Time Frame
Peri procedure
Other Pre-specified Outcome Measures:
Title
Safety Adverse Events
Description
Adverse events/serious adverse event rates related to the procedure or device
Time Frame
1 week and 1 month post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Waite, RN
Phone
352-281-7747
Email
robin@medaviseconsulting.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Bell, PhD
Phone
(440) 772-1421
Email
abell@clearimg.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad M Hanson, MD
Organizational Affiliation
Desert Orthopaedic Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Desert Orthopaedic Center
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad M Hanson, MD
Phone
702-263-9082
First Name & Middle Initial & Last Name & Degree
Richard S Woodworth, MD
First Name & Middle Initial & Last Name & Degree
Roger A Fontes, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
C Scope Visualization System Prospective Study
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