Clinical trial NCT00858052: Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Implants
Keywords: breast implants
saline
Lead sponsor: Ideal Implant Incorporated
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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

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.
timeFrame: 2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs.
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Folsom
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Modesto
country: United States
state: California
city: Riverside
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Stockton
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Loxahatchee Groves
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ponte Vedra Beach
country: United States
state: Florida
city: Duluth
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Allen
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Southlake
country: United States
state: Texas
Study officials:
References:
citation: 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.