N/A
N=100
3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery
Hypomastia · Primary Breast Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT01964105 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Breast Q Augmentation Module — 494.5; 503.4; 420 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3D Imaging (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breast Q Augmentation Module |
494.5; 503.4; 420 | — |
Summary
The purpose of this trial is to evaluate the impact of incorporating three-dimensional (3D)imaging during preoperative consultation on patient reported outcomes in primary breast augmentation surgery. 3D imaging is an innovative technology that allows the surgeon to share with images how one could look after one's procedure. The patient's assessment will be collected using the Breast Q, an objective questionnaire that captures patient satisfaction with breast augmentation.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Scheduled for elective breast augmentation cosmetic procedure.
Exclusion Criteria
- Breast reconstruction for malignancy
- Cognitively unable to provide informed consent.
Data sourced from ClinicalTrials.gov (NCT01964105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.