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Completed

NCT Number: NCT05153863

C Scope Visualization System Prospective Study

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

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Key information

Conditions

Knee Injuries and Disorders Disease Knee Injuries Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Shoulder Disease Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Desert Orthopaedic Center

Henderson, Nevada, 89052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Physician-rated procedural (diagnostic only) illumination and visualization with the C-Scope Visualization System

    Time frame: 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 outcomes

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

    Time frame: Peri procedure

    Physician-rated confidence of diagnosis following needle arthroscopy attributed to visualization performance of the device using a 5-point scale

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

    Time frame: Peri procedure

    Physician-rated needle arthroscopy procedural ease using a 5- point scale

  3. Procedure time with the C-Scope Visualization System

    Time frame: Peri procedure

    Procedure time (from start of arthroscopy to end of procedure)

Other outcomes

  1. Safety Adverse Events

    Time frame: 1 week and 1 month post procedure

    Adverse events/serious adverse event rates related to the procedure or device

Sponsors and collaborators

Lead sponsor

CIT Ortho

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2021
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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