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

Phase

N/A

Condition

Breast Implants

Treatment

N/A

Clinical Study ID

NCT00858052

G 080055

Ages > 18
Female
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Bilateral primary breast augmentation-dissatisfaction with breast size
Bilateral replacement augmentation-has had previous silicone saline-filled orgel-filled breast implants

Exclusion

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

Study Design

February 01, 2009

May 31, 2021

Study Description

For complete information about the clinical trial, see link in the reference section.

Connect with a study center

Beverly Hills, California
United States
Site Not Available
Folsom, California
United States
Site Not Available
Huntington Beach, California
United States
Site Not Available
Modesto, California
United States
Site Not Available
Riverside, California
United States
Site Not Available
Sacramento, California
United States
Site Not Available
Santa Monica, California
United States
Site Not Available
Stockton, California
United States
Site Not Available
Boca Raton, Florida
United States
Site Not Available
Boynton Beach, Florida
United States
Site Not Available
Fort Lauderdale, Florida
United States
Site Not Available
empty
Ft. Lauderdale, Florida
United States
Site Not Available
Hollywood, Florida
United States
Site Not Available
Jacksonville, Florida
United States
Site Not Available
empty
Loxahatchee, Florida
United States
Site Not Available
Loxahatchee Groves, Florida
United States
Site Not Available
Miami, Florida
United States
Site Not Available
Ponte Vedra Beach, Florida
United States
Site Not Available
Duluth, Georgia
United States
Site Not Available
Marietta, Georgia
United States
Site Not Available
Roswell, Georgia
United States
Site Not Available
Allen, Texas
United States
Site Not Available
Dallas, Texas
United States
Site Not Available
Houston, Texas
United States
Site Not Available
Irving, Texas
United States
Site Not Available
Southlake, Texas
United States
Site Not Available

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