C Scope Visualization System Prospective Study

NCT05153863 | Completed FDA Device

• 1 other identifier: ZSC-DVER-330-02-PR32
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Injuries and Disorders; Shoulder Disease; Shoulder Injuries

Keywords

Visualization; Illumination; Arthroscopic Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Physician-rated confidence of diagnosis with the C-Scope Visualization System

  Peri procedure

• Physician-rated needle arthroscopy procedural ease with the C-Scope Visualization System

  Peri procedure

• Procedure time with the C-Scope Visualization System

  Peri procedure

Other Outcomes (1)

• Safety Adverse Events

  1 week and 1 month post procedure

Study Arms (1)

Single Arm C-Scope Visualization System

EXPERIMENTAL

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

Interventions

C Scope Visualization System DEVICE

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.

Single Arm C-Scope Visualization System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CIT Ortho: lead

Study Sites (1)

Desert Orthopaedic Center

Henderson, Nevada, 89052, United States

Location

MeSH Terms

Conditions

Knee Injuries; Disease; Shoulder Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chad M Hanson, MD

  Desert Orthopaedic Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Evaluation of the performance and safety of the C Scope Visualization System in the illumination and visualization of joints during diagnostic procedures

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 10, 2021
• Study Start: January 20, 2022
• Primary Completion: June 7, 2023
• Study Completion: July 7, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)