CompletedNot Applicable

Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants

United States500 participantsStarted 2009-02

Plain-language summary

The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

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

Inclusion Criteria: * Bilateral primary breast augmentation-dissatisfaction with breast size * Bilateral replacement augmentation-has had previous silicone saline-filled or gel-filled breast implants Exclusion Criteria: * Diagnosis of active cancer of any type * Has ever been diagnosed with breast cancer * Has pre-malignant breast disease * Has tissue characteristics incompatible with an implant * Has unrealistic or unreasonable expectations of the procedure results

What they're measuring

Determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants.

Timeframe: 2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs.

Trial details

NCT IDNCT00858052

SponsorIdeal Implant Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02

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