Sientra Post-Approval Study

NCT ID: NCT01639053

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5498 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2025-03-31

Brief Summary

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This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.

Detailed Description

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Conditions

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Breast Augmentation Breast Reconstruction Breast Revision

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gel Participants

No interventions assigned to this group

Control Participants

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Genetic female with US residency
2. Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation
3. Agrees to Sientra study requirements

Exclusion Criteria

1. Has an active infection anywhere in body
2. Has active cancer without adequate treatment
3. Currently pregnant or nursing
4. Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements
5. If control participant, has undergone breast implant surgery with silicone gel-filled breast implants
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tiger Biosciences, LLC.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sientra, Inc.

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Sientra, Inc.

Santa Barbara, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP-1007

Identifier Type: -

Identifier Source: org_study_id

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