C Scope Visualization System Prospective Study

Not Applicable

Completed

• Conditions: Knee Injuries and Disorders; Shoulder Disease; Shoulder Injuries

• Registration Number: NCT05153863
• Lead Sponsor: CIT Ortho

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.

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-10
• Study Start: 2022-01-20
• Primary Completion: 2023-06-07
• Study Completion: 2023-07-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Procedure time with the C-Scope Visualization System	Peri procedure	Procedure time (from start of arthroscopy to end of procedure)
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
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

Trial Locations

Locations (1)

Desert Orthopaedic Center; 🇺🇸 Henderson, Nevada, United States