C Scope Visualization System Prospective Study

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

Evaluation of the performance and safety of the C Scope Visualization System

Study Overview

• Status: Completed
• Conditions: Shoulder Injuries; Shoulder Disease; Knee Injuries and Disorders
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Desert Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: CIT Ortho
• Investigators: Principal Investigator: Chad M Hanson, MD, Desert Orthopaedic Center

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Visualization; Illumination; Arthroscopic Procedures
• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Shoulder Injuries; Knee Injuries
• Other Study ID Numbers: ZSC-DVER-330-02-PR32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes