Study Results
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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UNKNOWN
5498 participants
OBSERVATIONAL
2012-04-30
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
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
18 Years
FEMALE
Yes
Sponsors
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Tiger Biosciences, LLC.
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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CP-1007
Identifier Type: -
Identifier Source: org_study_id
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