3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery

NCT01964105 | Completed Results

• 1 other identifier: 201210065
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypomastia; Primary Breast Augmentation

Keywords

Hypomastia; Augmentation; Breast; 3D; Breast Q

Outcome Measures

Primary Outcomes (1)

• Breast Q Augmentation Module

  BREAST-Q is a validated measures of patient reported outcomes (this is not an acronym). For this study we utilized the preoperative and postoperative BREAST -Q designed to analyze outcomes following breast augmentation The BREAST-Q is measured as a Q-score on a scale of 0-100. 0 is a poor score, 100 is an optimal score. Q-scores stand independently and are not combined to create a total score.

  up to 6 months postop visit.

Study Arms (3)

3D Imaging Simulation

EXPERIMENTAL

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

Device: 3D Imaging

Standard Preoperative Evaluation

NO INTERVENTION

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

Non-Randomized Cohort: 3D Imaging

OTHER

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

Device: 3D Imaging

Interventions

3D Imaging DEVICE

Also known as: Vectra 3D

3D Imaging Simulation; Non-Randomized Cohort: 3D Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Scheduled for elective breast augmentation cosmetic procedure.

You may not qualify if:

• Breast reconstruction for malignancy
• Cognitively unable to provide informed consent.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Allergan: collaborator

Study Sites (1)

West County Plastic Surgeons of Washington University

St Louis, Missouri, 63141, United States

Location

Related Publications (3)

• Tepper OM, Unger JG, Small KH, Feldman D, Kumar N, Choi M, Karp NS. Mammometrics: the standardization of aesthetic and reconstructive breast surgery. Plast Reconstr Surg. 2010 Jan;125(1):393-400. doi: 10.1097/PRS.0b013e3181c4966e. No abstract available.

  PMID: 20048631 BACKGROUND

• Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.

  PMID: 19644246 BACKGROUND

• Overschmidt B, Qureshi AA, Parikh RP, Yan Y, Tenenbaum MM, Myckatyn TM. A Prospective Evaluation of Three-Dimensional Image Simulation: Patient-Reported Outcomes and Mammometrics in Primary Breast Augmentation. Plast Reconstr Surg. 2018 Aug;142(2):133e-144e. doi: 10.1097/PRS.0000000000004601.

  PMID: 30045174 DERIVED

Related Links

• Click here for Washington University's study location.

MeSH Terms

Interventions

Imaging, Three-Dimensional

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: TERENCE MICHAEL MYCKATYN, PI, PROFESSOR, PLASTIC SURGERY
• Organization: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, SAINT LOUIS

myckatyn@wustl.edu

314-362-4263

Study Officials

• Terence M Myckatyn, MD, FACS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 17, 2013
• Study Start: November 1, 2012
• Primary Completion: May 16, 2017
• Study Completion: May 16, 2017
• Last Updated: December 26, 2017
• Results First Posted: December 26, 2017

Record last verified: 2017-11

Locations

US (1)