TerminatedNot Applicable

Post Market Clinical Experience Study of Sientra 207 Breast Implants

Stopped: Low enrollment

United States113 participantsStarted 2016-08

Plain-language summary

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

Age range22 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Investigator Overall Satisfaction Questionnaire

Timeframe: 3 months

Investigator Overall Satisfaction Questionnaire

Timeframe: 6 months

Investigator Overall Satisfaction Questionnaire

Timeframe: 12 months

NCT IDNCT02905617

SponsorTiger Biosciences, LLC.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-07-15