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Post Market Clinical Experience Study of Sientra 207 Breast Implants

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ClinicalTrials.gov Identifier: NCT02905617
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sientra, Inc.

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

Condition or disease
Breast Augmentation Breast Revision-Augmentation

Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Market Clinical Experience Study of the Sientra 207 High-Strength Cohesive Plus (HSC+) Breast Implants in Primary and Revision Augmentation Participants
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Primary Augmentation
Revision Augmentation



Primary Outcome Measures :
  1. Investigator Overall Satisfaction Questionnaire [ Time Frame: 3 months ]
  2. Investigator Overall Satisfaction Questionnaire [ Time Frame: 6 months ]
  3. Investigator Overall Satisfaction Questionnaire [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women who receive Sientra Silicone 207 Gel Breast Implants for primary augmentation or revision augmentation
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905617


Contacts
Contact: Sientra, Inc.

Locations
United States, California
Sientra, Inc. Recruiting
Santa Barbara, California, United States, 93117
Contact: Sientra, Inc    888-708-0808      
Sponsors and Collaborators
Sientra, Inc.
Investigators
Study Director: Sientra, Inc. Sponsor GmbH

Publications of Results:
Responsible Party: Sientra, Inc.
ClinicalTrials.gov Identifier: NCT02905617     History of Changes
Other Study ID Numbers: CP-1008
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sientra, Inc.:
Breast Augmentation
Breast Revision-Augmentation