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

Ideal Implant

Status: Completed

Conditions: Breast Implants

Treatments: Device: Saline-filled breast implant [IDEAL IMPLANT (R)]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858052

G 080055

Details and patient eligibility

About

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.

Full description

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

Enrollment: 500 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

breast augmentation

Experimental group

Description:

breast implant

Treatment:

Device: Saline-filled breast implant [IDEAL IMPLANT (R)]