Status:
COMPLETED
Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants
Lead Sponsor:
Ideal Implant Incorporated
Conditions:
Breast Implants
Eligibility:
FEMALE
18+ years
Phase:
NA
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 silico...
Detailed Description
For complete information about the clinical trial, see link in the reference section.
Eligibility Criteria
Inclusion
- Bilateral primary breast augmentation-dissatisfaction with breast size
- Bilateral replacement augmentation-has had previous silicone saline-filled or gel-filled breast implants
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00858052
Start Date
February 1 2009
End Date
May 1 2021
Last Update
September 30 2021
Active Locations (24)
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1
Beverly Hills, California, United States
2
Folsom, California, United States
3
Huntington Beach, California, United States
4
Modesto, California, United States