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Seri Surgical Scaffold Support of the Lower Pole of the Breast

Seri Surgical Scaffold (TM) Support of the Lower Pole of the Breasts in Augmentation Mastopexy or Breast Reduction Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02016612
Acronym
SeriSupport
Enrollment
76
Registered
2013-12-20
Start date
2013-10-31
Completion date
2016-11-30
Last updated
2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Ptosis of the Breast

Keywords

Recurrent, Ptosis, Reduction, Mammoplasty, Mastopexy

Brief summary

Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D Imaging system reporting the amount of breast tissue above and below the nipple level.

Detailed description

Patients having augmentation mastopexy or breast reduction will be informed about Seri Scaffold and allowed to have Seri support included in their surgery or not. If the choose the scaffold will be placed under the skin in the lower pole of the breast as an internal hammock to help take weight off of the breast and potentially help prevent future stretch of the lower pole.

Interventions

DEVICESeri 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.

Sponsors

Allergan Medical
CollaboratorINDUSTRY
Bengtson Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

Age =\>18 years * requesting procedure * No active cancer or infection

Exclusion criteria

* Known allergy to silk * Pregnant or lactating

Design outcomes

Primary

MeasureTime frameDescription
Nipple to Fold Measurement on Stretch1 year post opThe Nipple to fold will be measured manually over time to 1 year

Secondary

MeasureTime frameDescription
Percent Breast Tissue Above Nipple1 year post opThe percentage of breast tissue above and below the horizontal plane of the nipple over time

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
25
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.
25
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.
26
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.
61
Total137

Baseline characteristics

CharacteristicMastopexy, Implant no Seri ScaffoldBreast Reduction With Seri SupportAugmentation Mastopexy, Implant and SeriReduction, Mastopexy No Implant, No SeriTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
25 Participants26 Participants61 Participants25 Participants137 Participants
Age, Continuous38 years48 years37 years47 years42 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants0 Participants1 Participants4 Participants
Race (NIH/OMB)
Black or African American
0 Participants3 Participants0 Participants2 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
23 Participants22 Participants61 Participants22 Participants128 Participants
Region of Enrollment
United States
25 Participants26 Participants61 Participants25 Participants137 Participants
Sex: Female, Male
Female
25 Participants26 Participants61 Participants25 Participants137 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
3 / 252 / 253 / 262 / 61
serious
Total, serious adverse events
0 / 250 / 253 / 262 / 61

Outcome results

Primary

Nipple to Fold Measurement on Stretch

The Nipple to fold will be measured manually over time to 1 year

Time frame: 1 year post op

ArmMeasureValue (MEAN)
Reduction, Mastopexy No Implant, No SeriNipple to Fold Measurement on Stretch2.3 centimeters
Mastopexy, Implant no Seri ScaffoldNipple to Fold Measurement on Stretch2.5 centimeters
Breast Reduction With Seri SupportNipple to Fold Measurement on Stretch1.4 centimeters
Augmentation Mastopexy, Implant and SeriNipple to Fold Measurement on Stretch1.4 centimeters
Secondary

Percent Breast Tissue Above Nipple

The percentage of breast tissue above and below the horizontal plane of the nipple over time

Time frame: 1 year post op

ArmMeasureValue (MEAN)
Reduction, Mastopexy No Implant, No SeriPercent Breast Tissue Above Nipple35 percentage of volume
Mastopexy, Implant no Seri ScaffoldPercent Breast Tissue Above Nipple30 percentage of volume
Breast Reduction With Seri SupportPercent Breast Tissue Above Nipple15 percentage of volume
Augmentation Mastopexy, Implant and SeriPercent Breast Tissue Above Nipple18 percentage of volume

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026