C Scope Visualization System Prospective Study

CIT Ortho

Status: Completed

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

Treatments: Device: C Scope Visualization System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05153863

ZSC-DVER-330-02-PR32

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Single Arm C-Scope Visualization System

Experimental group

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.

Treatment:

Device: C Scope Visualization System