A Study to Evaluate the Safety of the Goldilocks Procedure with Implant-Based Reconstruction
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: 19-008324
- Jacksonville, Florida: 19-008324
- Scottsdale/Phoenix, Arizona: 19-008324
Sponsor Protocol Number: 19-008324
About this study
The purpose of this study is to assess outcomes, satisfaction and aesthetics of two different breast reconstruction techniques (Goldilocks alone, and Goldilocks with Implant-Based Reconstruction) and compare its safety, patient satisfaction, aesthetic evaluation and complications.
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:
- Female older than 18 years who underwent Goldilocks procedure for breast reconstruction.
Exclusion Criteria:
- Follow-up less than 12 months.
- Don’t consent to participate.
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 |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Oscar Manrique, M.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Jacksonville, Fla.
Mayo Clinic principal investigator Oscar Manrique, M.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Oscar Manrique, M.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available