Post Market Clinical Experience Study of Sientra 207 Breast Implants

NCT02905617 | Terminated

• 1 other identifier: CP-1008
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Augmentation; Breast Revision-Augmentation

Keywords

Breast Augmentation; Breast Revision-Augmentation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Primary Augmentation

Subjects undergoing general breast enlargement receiving Sientra Style 207 Silicone Gel Breast Implant.

Device: Sientra 207 Silicone Gel Breast Implant

Revision Augmentation

Subjects undergoing revision surgery with Sientra Style 207 Silicone Gel Breast Implant to revise or improve the result of a primary breast augmentation surgery.

Device: Sientra 207 Silicone Gel Breast Implant

Interventions

Sientra 207 Silicone Gel Breast Implant DEVICE

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

Primary Augmentation; Revision Augmentation

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who receive Sientra Silicone 207 Gel Breast Implants for primary augmentation or revision augmentation

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tiger Biosciences, LLC.: lead

Study Sites (1)

Sientra, Inc.

Santa Barbara, California, 93117, United States

Location

Related 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):40S-48S. doi: 10.1097/PRS.0000000000004353.

  PMID: 29595717 RESULT

Study Officials

• Sientra, Inc.

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 19, 2016
• Study Start: August 1, 2016
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)