Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants
NCT ID: NCT00858052
Last Updated: 2021-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
500 participants
INTERVENTIONAL
2009-02-28
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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breast augmentation
breast implant
Saline-filled breast implant [IDEAL IMPLANT (R)]
Breast augmentation
Interventions
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Saline-filled breast implant [IDEAL IMPLANT (R)]
Breast augmentation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bilateral replacement augmentation-has had previous silicone saline-filled or gel-filled breast implants
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Ideal Implant Incorporated
INDUSTRY
Responsible Party
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Locations
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Beverly Hills, California, United States
Folsom, California, United States
Huntington Beach, California, United States
Modesto, California, United States
Riverside, California, United States
Sacramento, California, United States
Santa Monica, California, United States
Stockton, California, United States
Boca Raton, Florida, United States
Boynton Beach, Florida, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Loxahatchee Groves, Florida, United States
Miami, Florida, United States
Ponte Vedra Beach, Florida, United States
Duluth, Georgia, United States
Marietta, Georgia, United States
Roswell, Georgia, United States
Allen, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Southlake, Texas, United States
Countries
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References
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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.
Related Links
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Click here for more information about study: "Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants
Other Identifiers
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G 080055
Identifier Type: -
Identifier Source: org_study_id
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