Overview

This trial is active, not recruiting.

Condition focus = breast implants
Treatment saline-filled breast implant [ideal implant (r)]
Sponsor Ideal Implant Incorporated
Start date February 2009
End date February 2012
Trial size 500 participants
Trial identifier NCT00858052, G 080055

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
breast implant
saline-filled breast implant [ideal implant (r)] IDEAL IMPLANT (R) Saline-filled Breast Implant
Breast augmentation

Primary Outcomes

Measure
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.

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official 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
Description For complete information about the clinical trial, see www.idealimplant.com
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Ideal Implant Incorporated.