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NCT02905617 Clinical Trial

Post Market Clinical Experience Study of Sientra 207 Breast Implants

Breast Augmentation Clinical Trial

Official title:
Post Market Clinical Experience Study of the Sientra 207 High-Strength Cohesive Plus (HSC+) Breast Implants in Primary and Revision Augmentation Participants

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02905617
Other study ID # CP-1008
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date August 2016
Est. completion date July 15, 2020

Study information
Verified date April 2023
Source Sientra, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 113
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 22 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Sientra 207 Silicone Gel Breast Implant
The Sientra 207 Silicone Gel Breast Implant is a textured, round device with high-strength cohesive plus (HSC+) silicone gel fill.

Locations
Country Name City State
United States Sientra, Inc. Santa Barbara California

Sponsors (1)
Lead Sponsor Collaborator
Sientra, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schwartz MR, Haws MJ, Phillips G. Results of the Postmarket Clinical Study of the Sientra 207 Highly Cohesive Gel Breast Implants in Primary and Revision Augmentation. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):40 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Investigator Overall Satisfaction Questionnaire 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. 3 months
Primary Investigator Overall Satisfaction Questionnaire 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. 6 months
Primary Investigator Overall Satisfaction Questionnaire 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. 12 months
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