Knee Injuries and DisordersNCT05153863
C Scope Visualization System Prospective Study
A study testing C Scope Visualization System in people with Knee Injuries and Disorders and Shoulder Disease, run by CIT Ortho at 1 site in United States.
Trial summary
Evaluation of the performance and safety of the C Scope Visualization System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Injuries and Disorders, Shoulder Disease, Shoulder Injuries
- What is being tested?
- C Scope Visualization System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Performance and Safety of the C Scope Visualization System in Arthroscopic Procedures - A Prospective Study
Evaluation of the performance and safety of the C Scope Visualization System
Read the detailed 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.
- Being tested
- C Scope Visualization System
- Keywords
- Visualization, Illumination, Arthroscopic Procedures
- Medical subject headings
- Knee Injuries, Disease, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C Scope Visualization SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: C Scope Visualization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: Peri procedure
Secondary outcomes (3)
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
Measured: Peri procedure
Physician-rated needle arthroscopy procedural ease with the C-Scope Visualization System
Physician-rated needle arthroscopy procedural ease using a 5- point scale
Measured: Peri procedure
Procedure time with the C-Scope Visualization System
Procedure time (from start of arthroscopy to end of procedure)
Measured: Peri procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start20 Jan 2022
- Primary completion7 Jun 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluation of the performance and safety of the C Scope Visualization System in the illumination and visualization of joints during diagnostic procedures
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIT Ortho
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chad M Hanson, MD, Principal investigator, Desert Orthopaedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153863
- Sponsor's protocol ID
- ZSC-DVER-330-02-PR32
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of the C Scope Visualization System in Arthroscopic Procedures - A Prospective Study
- ClinicalTrials.gov ID
- NCT05153863
- Acronym / sponsor ID
- ZSC-DVER-330-02-PR32
- Keywords
- Visualization, Illumination, Arthroscopic Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- CIT OrthoIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the performance and safety of the C Scope Visualization System
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluation of the performance and safety of the C Scope Visualization System in the illumination and visualization of joints during diagnostic procedures
| Arm | Type | Receives |
|---|---|---|
| Single Arm C-Scope Visualization System | Experimental | Device: C Scope Visualization SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C Scope Visualization SystemThe 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 | Single Arm C-Scope Visualization System |
Primary outcome
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:
3 secondary outcomes
Physician-rated confidence of diagnosis with the C-Scope Visualization System
Time frame: Peri procedure
Physician-rated needle arthroscopy procedural ease with the C-Scope Visualization System
Time frame: Peri procedure
Procedure time with the C-Scope Visualization System
Time frame: Peri procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad M Hanson, MD principal investigator
Desert Orthopaedic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C Scope Visualization System in people with Knee Injuries and Disorders and Shoulder Disease, run by CIT Ortho at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician-rated procedural (diagnostic only) illumination and visualization with the C-Scope Visualization System (time frame: Peri procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.