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

Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants in Women Who Are Undergoing Primary Breast Augmentation or Replacement of Existing Augmentation Implants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00858052

Enrollment

500

Registered

2009-03-09

Start date

2009-02-28

Completion date

2021-05-31

Last updated

2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Implants

Keywords

breast implants, saline

Brief 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.

Detailed description

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

Interventions

DEVICESaline-filled breast implant [IDEAL IMPLANT (R)]

Breast augmentation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026