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

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.

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Key information

Conditions

Breast Implants

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beverly Hills, California, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Breast augmentation

Other names: IDEAL IMPLANT (R) Saline-filled Breast Implant

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.

Sponsors and collaborators

Lead sponsor

Ideal Implant Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2021
First posted: Mar 9, 2009
Registry last updated: Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed