Validation of the Vectra XT Imaging System for Volume Analysis of the Breast
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
- Rochester, Minnesota: 14-003908
Sponsor Protocol Number: 14-003908
About this study
The objective of the present study is to prospectively enroll Mayo Clinic breast reconstruction patients with tissue expanders in place. We will then use the Vectra XT Imaging System to capture images of patients both pre- and post- tissue expansion to determine if the Vectra system accurately captures volume changes when a known volume of fluid is injected into a tissue expander. This will enable us to determine if the Vectra XT Imaging System can be used for other applications of volume analysis.
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:
- Mayo Clinic patients aged 18 and older who have undergone tissue expander-based breast reconstruction and are currently undergoing expansion.
Exclusion criteria:
- Ppatients who are pregnant or currently lactating.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Karim Bakri, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available