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

Ideal Implant Incorporated500 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Breast Implants

Interventions

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

Breast augmentation

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (24)

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

Folsom, California, United States

Outcomes

Primary Outcomes

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.

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

Data from ClinicalTrials.gov

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