A Study of Diagnostic Accuracy of The Mi-eye2™ Compared to Magnetic Resonance Imaging in Knee Arthroscopy Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 16-007678
Sponsor Protocol Number: CP-002
About this study
The objective of this study is to investigate the clinical utility of the mi-eye 2™ device. This will be done by measuring the frequency with which the MRI and mi-eye 2™, respectively, change the Investigator’s primary diagnosis, confidence in diagnosis and management plan, in a routine clinical setting.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subject is 18 to 64 years of age, inclusive
- Subject is determined by Investigator to need further exploration of knee pathology via MRI for suspected intraarticular pathology such as:
- Meniscal pathology
- Non-acute ACL pathology
- Chondral defects or damage
- Occult loose bodies
- Other suspected internal derangement
- Subject has participated in the Informed Consent Process and has signed the IRB/EC approved Informed Consent Form.
- Subject is willing and able to complete study procedures per protocol
Exclusion Criteria:
- Body Mass Index (BMI) > 40
- Subject does not require MRI per Standard of Care
- Subject has a current MRI that was obtained ≤6 months prior to enrollment
- Contraindications for MRI
- Previous surgery on knee
- Kellgren-Lawrence osteoarthritis grade ≥2
- Subject is currently participating in any other surgical intervention study
- Acute (within 7 days), traumatic hemarthroses
- Acute (within 7 days) ACL or other acute ligamentous injury resulting in acute, traumatic hemarthrosis
- Active systemic infection
- Subject is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc).
- MRI results demonstrating concomitant medical condition requiring priority attention
- Subject is accepting workers compensation or is involved in active litigation related to knee injury.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Anikar Chhabra, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available