C Scope Visualization System Prospective Study

NCT ID: NCT05153863

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2023-07-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Knee Injuries and Disorders Shoulder Disease Shoulder Injuries

Keywords

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Visualization Illumination Arthroscopic Procedures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Evaluation of the performance and safety of the C Scope Visualization System in the illumination and visualization of joints during diagnostic procedures
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm 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.

Group Type EXPERIMENTAL

C Scope Visualization System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CIT Ortho

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chad M Hanson, MD

Role: PRINCIPAL_INVESTIGATOR

Desert Orthopaedic Center

Locations

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Desert Orthopaedic Center

Henderson, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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ZSC-DVER-330-02-PR32

Identifier Type: -

Identifier Source: org_study_id