Trial Outcomes & Findings for Seri Surgical Scaffold Support of the Lower Pole of the Breast (NCT NCT02016612)
NCT ID: NCT02016612
Last Updated: 2018-02-13
Results Overview
The Nipple to fold will be measured manually over time to 1 year
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
1 year post op
Results posted on
2018-02-13
Participant Flow
Participant milestones
| Measure |
Reduction, Mastopexy No Implant, No Seri
Patients undergoing reduction or mastopexy but no implant is used and no Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Mastopexy, Implant no Seri Scaffold
Mastopexy with implant, No Seri support is used
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Breast Reduction With Seri Support
Patients undergoing breast reduction with the use of Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Augmentation Mastopexy, Implant and Seri
Augmentation Mastopexy patients where Seri Scaffold is placed
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
26
|
61
|
|
Overall Study
COMPLETED
|
25
|
25
|
26
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seri Surgical Scaffold Support of the Lower Pole of the Breast
Baseline characteristics by cohort
| Measure |
Augmentation Mastopexy, Implant and Seri
n=61 Participants
Augmentation Mastopexy patients where Seri Scaffold is placed
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Total
n=137 Participants
Total of all reporting groups
|
Reduction, Mastopexy No Implant, No Seri
n=25 Participants
Patients undergoing reduction or mastopexy but no implant is used and no Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Mastopexy, Implant no Seri Scaffold
n=25 Participants
Mastopexy with implant, No Seri support is used
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Breast Reduction With Seri Support
n=26 Participants
Patients undergoing breast reduction with the use of Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37 years
n=4 Participants
|
42 years
n=21 Participants
|
47 years
n=5 Participants
|
38 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post opThe Nipple to fold will be measured manually over time to 1 year
Outcome measures
| Measure |
Reduction, Mastopexy No Implant, No Seri
n=25 Participants
Patients undergoing reduction or mastopexy but no implant is used and no Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Mastopexy, Implant no Seri Scaffold
n=25 Participants
Mastopexy with implant, No Seri support is used
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Breast Reduction With Seri Support
n=26 Participants
Patients undergoing breast reduction with the use of Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Augmentation Mastopexy, Implant and Seri
n=61 Participants
Augmentation Mastopexy patients where Seri Scaffold is placed
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
|---|---|---|---|---|
|
Nipple to Fold Measurement on Stretch
|
2.3 centimeters
Interval 1.2 to 4.2
|
2.5 centimeters
Interval 1.2 to 4.1
|
1.4 centimeters
Interval 0.5 to 2.6
|
1.4 centimeters
Interval 0.7 to 2.6
|
SECONDARY outcome
Timeframe: 1 year post opThe percentage of breast tissue above and below the horizontal plane of the nipple over time
Outcome measures
| Measure |
Reduction, Mastopexy No Implant, No Seri
n=25 Participants
Patients undergoing reduction or mastopexy but no implant is used and no Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Mastopexy, Implant no Seri Scaffold
n=25 Participants
Mastopexy with implant, No Seri support is used
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Breast Reduction With Seri Support
n=26 Participants
Patients undergoing breast reduction with the use of Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Augmentation Mastopexy, Implant and Seri
n=61 Participants
Augmentation Mastopexy patients where Seri Scaffold is placed
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
|---|---|---|---|---|
|
Percent Breast Tissue Above Nipple
|
35 percentage of volume
Interval 0.0 to 100.0
|
30 percentage of volume
Interval 0.0 to 100.0
|
15 percentage of volume
Interval 0.0 to 100.0
|
18 percentage of volume
Interval 0.0 to 100.0
|
Adverse Events
Reduction, Mastopexy No Implant, No Seri
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Mastopexy, Implant no Seri Scaffold
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Breast Reduction With Seri Support
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Augmentation Mastopexy, Implant and Seri
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reduction, Mastopexy No Implant, No Seri
n=25 participants at risk
Patients undergoing reduction or mastopexy but no implant is used and no Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Mastopexy, Implant no Seri Scaffold
n=25 participants at risk
Mastopexy with implant, No Seri support is used
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Breast Reduction With Seri Support
n=26 participants at risk
Patients undergoing breast reduction with the use of Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Augmentation Mastopexy, Implant and Seri
n=61 participants at risk
Augmentation Mastopexy patients where Seri Scaffold is placed
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
seroma
|
0.00%
0/25 • 1 year
|
0.00%
0/25 • 1 year
|
11.5%
3/26 • Number of events 3 • 1 year
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
dehiscence
|
0.00%
0/25 • 1 year
|
0.00%
0/25 • 1 year
|
11.5%
3/26 • Number of events 3 • 1 year
|
3.3%
2/61 • Number of events 2 • 1 year
|
Other adverse events
| Measure |
Reduction, Mastopexy No Implant, No Seri
n=25 participants at risk
Patients undergoing reduction or mastopexy but no implant is used and no Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Mastopexy, Implant no Seri Scaffold
n=25 participants at risk
Mastopexy with implant, No Seri support is used
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Breast Reduction With Seri Support
n=26 participants at risk
Patients undergoing breast reduction with the use of Seri support
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
Augmentation Mastopexy, Implant and Seri
n=61 participants at risk
Augmentation Mastopexy patients where Seri Scaffold is placed
Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
skin dehiscence
|
8.0%
2/25 • Number of events 2 • 1 year
|
4.0%
1/25 • Number of events 1 • 1 year
|
11.5%
3/26 • Number of events 3 • 1 year
|
3.3%
2/61 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
4.0%
1/25 • Number of events 1 • 1 year
|
4.0%
1/25 • Number of events 1 • 1 year
|
0.00%
0/26 • 1 year
|
0.00%
0/61 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place