C Scope Visualization System Prospective Study

Shoulder Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153863
• Other study ID #: ZSC-DVER-330-02-PR32
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: July 7, 2023

Study information

• Verified date: November 2023
• Source: CIT Ortho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries
• Knee Injuries and Disorders
• Shoulder Disease
• Shoulder Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Desert Orthopaedic Center	Henderson	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
CIT Ortho

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Adverse Events	Adverse events/serious adverse event rates related to the procedure or device	1 week and 1 month post procedure
Primary	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	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
Secondary	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
Secondary	Procedure time with the C-Scope Visualization System	Procedure time (from start of arthroscopy to end of procedure)	Peri procedure