Post Market Clinical Experience Study of Sientra 207 Breast Implants

Terminated

• Conditions: Breast Augmentation; Breast Revision-Augmentation
• Interventions: Device: Sientra 207 Silicone Gel Breast Implant

• Registration Number: NCT02905617
• Lead Sponsor: Sientra, Inc.

Brief Summary

A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants

Detailed Description

This study is designed to prospectively collect surgeon and participant satisfaction with the Sientra 207 implants in primary and revision augmentation participants over a 12-month time frame.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 113

Inclusion Criteria

1. Is a candidate for primary or revision breast augmentation and is at least 22 years of age,
2. Agrees to Sientra study requirements and to comply with office follow-up visits at months 3, 6 and 12.

Exclusion Criteria

1. Does not meet the Investigator's standard eligibility for breast augmentation or revision surgery
2. Surgeon is planning to use acellular dermal matrix (ADM) or surgical mesh and/or recommend postoperative massage.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Augmentation	Sientra 207 Silicone Gel Breast Implant	Subjects undergoing general breast enlargement receiving Sientra Style 207 Silicone Gel Breast Implant.
Revision Augmentation	Sientra 207 Silicone Gel Breast Implant	Subjects undergoing revision surgery with Sientra Style 207 Silicone Gel Breast Implant to revise or improve the result of a primary breast augmentation surgery.

Primary Outcome Measures

Name	Time	Method
Investigator Overall Satisfaction Questionnaire	12 months	The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.

Trial Locations

Locations (1)

Sientra, Inc.; 🇺🇸 Santa Barbara, California, United States