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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00858052
Recruitment Status : Active, not recruiting
First Posted : March 9, 2009
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ideal Implant Incorporated

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.

Condition or disease Intervention/treatment Phase
Breast Implants Device: Saline-filled breast implant [IDEAL IMPLANT (R)] Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2009
Actual Primary Completion Date : February 2012
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: breast augmentation
breast implant
Device: Saline-filled breast implant [IDEAL IMPLANT (R)]
Breast augmentation
Other Name: IDEAL IMPLANT (R) Saline-filled Breast Implant




Primary Outcome Measures :
  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. [ Time Frame: 2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858052


Locations
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United States, California
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
United States, Florida
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
United States, Georgia
Duluth, Georgia, United States
Marietta, Georgia, United States
Roswell, Georgia, United States
United States, Texas
Allen, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Southlake, Texas, United States
Sponsors and Collaborators
Ideal Implant Incorporated
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ideal Implant Incorporated
ClinicalTrials.gov Identifier: NCT00858052    
Other Study ID Numbers: G 080055
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Ideal Implant Incorporated:
breast implants
saline