Trial Outcomes & Findings for Circumferential Periareolar Mastopexy Using SERI Surgical Scaffold (NCT NCT02293798)

Results Overview

areolar dilation of up to 6mm

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

12 months after SERI implantation

Results posted on

2019-09-10

Unit of analysis: SERI Mesh

Participant milestones
Measure	SERI Subjects receiving SERI for mastopexy silk surgical scaffold: surgical implant
Overall Study STARTED	13 26
Overall Study COMPLETED	13 26
Overall Study NOT COMPLETED	0 0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	SERI n=13 Participants Subjects receiving SERI for mastopexy silk surgical scaffold: surgical implant
Age, Categorical <=18 years	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants
Age, Continuous	32.85 Years n=13 Participants
Sex: Female, Male Female	13 Participants n=13 Participants
Sex: Female, Male Male	0 Participants n=13 Participants
Region of Enrollment United States	13 Participants n=13 Participants

Timeframe: 12 months after SERI implantation

areolar dilation of up to 6mm

Outcome measures
Measure	SERI n=13 Participants Subjects receiving SERI for mastopexy silk surgical scaffold: surgical implant
Number of Participants With Areolar Dilation of up to 6mm at 12 Months	13 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Mark Mofid, M.D.

Phone: 8589099000