Trial Outcomes & Findings for 3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery (NCT NCT01964105)
NCT ID: NCT01964105
Last Updated: 2017-12-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
up to 6 months postop visit.
Results posted on
2017-12-26
Participant Flow
Participant milestones
| Measure |
Standard Preoperative Evaluation
Control Group: Patients will receive standard preoperative evaluation (2D imaging).
Goal: 50 patients
|
Non-Randomized Cohort: 3D Imaging
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
3D Imaging
|
3D Imaging Simulation
Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients
3D Imaging
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
75
|
10
|
|
Overall Study
COMPLETED
|
13
|
62
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
13
|
0
|
Reasons for withdrawal
| Measure |
Standard Preoperative Evaluation
Control Group: Patients will receive standard preoperative evaluation (2D imaging).
Goal: 50 patients
|
Non-Randomized Cohort: 3D Imaging
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
3D Imaging
|
3D Imaging Simulation
Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients
3D Imaging
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
13
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
3D Imaging Simulation
n=10 Participants
The intervention group underwent computer simulation with the Vectra Sculptor package (Canfield Scientific Inc, Parsippany, NJ) in addition to control group preoperative evaluation.
|
Standard Preoperative Evaluation
n=13 Participants
The control group underwent tissue-based planning that was supplemented by review of photos obtained from magazines or the internet, and placement of sizers in a surgical bra. Control group patients underwent three-dimensional photography with the same system but were not simulated.
|
Non-Randomized Cohort: 3D Imaging
n=62 Participants
Since enrollment in the non-randomized arm was predicated upon a pre-existing desire for computer simulation, all of these patients received this intervention.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 23.1 • n=10 Participants
|
40.2 years
STANDARD_DEVIATION 11 • n=13 Participants
|
35.8 years
STANDARD_DEVIATION 8.2 • n=62 Participants
|
37.2 years
STANDARD_DEVIATION 8.0 • n=85 Participants
|
|
Sex/Gender, Customized
Female
|
10 Participants
n=10 Participants
|
13 Participants
n=13 Participants
|
62 Participants
n=62 Participants
|
85 Participants
n=85 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
13 Participants
n=13 Participants
|
62 Participants
n=62 Participants
|
85 Participants
n=85 Participants
|
|
Volume of Breast
|
494.5 cubic centimeters (cc)
STANDARD_DEVIATION 93 • n=10 Participants
|
503.4 cubic centimeters (cc)
STANDARD_DEVIATION 113.1 • n=13 Participants
|
420 cubic centimeters (cc)
STANDARD_DEVIATION 119.3 • n=62 Participants
|
441 cubic centimeters (cc)
STANDARD_DEVIATION 120.5 • n=85 Participants
|
|
BREAST-Q
|
63.6 units on a scale
STANDARD_DEVIATION 18.6 • n=10 Participants
|
70.1 units on a scale
STANDARD_DEVIATION 21.5 • n=13 Participants
|
64.8 units on a scale
STANDARD_DEVIATION 19.3 • n=62 Participants
|
64.6 units on a scale
STANDARD_DEVIATION 19.1 • n=85 Participants
|
PRIMARY outcome
Timeframe: up to 6 months postop visit.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.
Outcome measures
| Measure |
Standard Preoperative Evaluation
n=13 Participants
Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation Goal: 50 patients
3D Imaging
|
3D Imaging Simulation
n=10 Participants
Control Group: Patients will receive standard preoperative evaluation (2D imaging).
Goal: 50 patients
|
Non-Randomized Cohort: 3D Imaging
n=62 Participants
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
3D Imaging
|
|---|---|---|---|
|
Breast Q Augmentation Module
|
494.5 units on a scale
Standard Deviation 93
|
503.4 units on a scale
Standard Deviation 113.1
|
420 units on a scale
Standard Deviation 119.3
|
Adverse Events
Standard Preoperative Evaluation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3D Imaging Simulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Randomized Cohort: 3D Imaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
TERENCE MICHAEL MYCKATYN, PI, PROFESSOR, PLASTIC SURGERY
WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, SAINT LOUIS
Phone: 314-362-4263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place