Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants
1 other identifier
interventional
500
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedSeptember 30, 2021
September 1, 2021
3 years
March 5, 2009
September 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
breast augmentation
EXPERIMENTALbreast implant
Interventions
Breast augmentation
Eligibility Criteria
You may qualify if:
- Bilateral primary breast augmentation-dissatisfaction with breast size
- Bilateral replacement augmentation-has had previous silicone saline-filled or gel-filled breast implants
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Folsom, California, United States
Unknown Facility
Huntington Beach, California, United States
Unknown Facility
Modesto, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Stockton, California, United States
Unknown Facility
Boca Raton, Florida, United States
Unknown Facility
Boynton Beach, Florida, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Loxahatchee Groves, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Ponte Vedra Beach, Florida, United States
Unknown Facility
Duluth, Georgia, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Roswell, Georgia, United States
Unknown Facility
Allen, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Irving, Texas, United States
Unknown Facility
Southlake, Texas, United States
Related Publications (1)
Nichter LS, Hardesty RA, Anigian GM. IDEAL IMPLANT Structured Breast Implants: Core Study Results at 6 Years. Plast Reconstr Surg. 2018 Jul;142(1):66-75. doi: 10.1097/PRS.0000000000004460.
PMID: 29489559DERIVED
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 9, 2009
Study Start
February 1, 2009
Primary Completion
February 1, 2012
Study Completion
May 1, 2021
Last Updated
September 30, 2021
Record last verified: 2021-09