A Study to Evaluate User Feedback Using Affirm® Contrast Biopsy
Overview
Tab Title Description
Study type
ObservationalDescribes 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: 20-011621
NCT ID: NCT04671329
Sponsor Protocol Number: #20-03
About this study
The purpose of this study is to collect user and subject feedback on the design, use and operation of Affirm® Contrast Biopsy.
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:
- Females aged 40 years of age or older.
- Recommended for biopsy.
- Have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.
- Subject is able to read, understand, and sign the study specific informed consent form after the nature of the study has been fully explained to them
Exclusion Criteria:
- Subjects who require a Legally Authorized Representative (LAR)for Informed Consent.
- Subjects who, based on the physician’s judgement, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders.
- Subjects who have had a previous allergic reaction to IV contrast agent.
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 Bhavika Patel, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available