3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery

N/A

Waitlist Available

Led By Terence M Myckatyn, MD, FACS

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months postop visit.

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Hypomastia
Breast Augmentation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months postop visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months postop visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months postop visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Breast Q Augmentation Module

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Non-Randomized Cohort: 3D ImagingExperimental Treatment1 Intervention

Patients who refuse the option of randomization but otherwise meet the inclusion and exclusion criteria will be offered participation in this study as part of a non-randomized cohort. Goal: 50 Patients

Group II: 3D Imaging SimulationExperimental Treatment1 Intervention

Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients

Group III: Standard Preoperative EvaluationActive Control1 Intervention

Control Group: Patients will receive standard preoperative evaluation (2D imaging). Goal: 50 patients

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

3D Imaging

2012

N/A

~100