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

Sponsor
Ideal Implant Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00858052
Collaborator
(none)
500
Enrollment
24
Locations
1
Arm
146.9
Actual Duration (Months)
20.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Saline-filled breast implant [IDEAL IMPLANT (R)]
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual 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
Actual Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: breast augmentation

breast implant

Device: Saline-filled breast implant [IDEAL IMPLANT (R)]
Breast augmentation
Other Names:
  • IDEAL IMPLANT (R) Saline-filled Breast Implant

    		•

    Outcome Measures

    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. [2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beverly Hills California United States
    2 Folsom California United States
    3 Huntington Beach California United States
    4 Modesto California United States
    5 Riverside California United States
    6 Sacramento California United States
    7 Santa Monica California United States
    8 Stockton California United States
    9 Boca Raton Florida United States
    10 Boynton Beach Florida United States
    11 Fort Lauderdale Florida United States
    12 Hollywood Florida United States
    13 Jacksonville Florida United States
    14 Loxahatchee Groves Florida United States
    15 Miami Florida United States
    16 Ponte Vedra Beach Florida United States
    17 Duluth Georgia United States
    18 Marietta Georgia United States
    19 Roswell Georgia United States
    20 Allen Texas United States
    21 Dallas Texas United States
    22 Houston Texas United States
    23 Irving Texas United States
    24 Southlake Texas United States

    Sponsors and Collaborators

    • Ideal Implant Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Ideal Implant Incorporated
    ClinicalTrials.gov Identifier:
    NCT00858052
    Other Study ID Numbers:
    • G 080055
    First Posted:
    Mar 9, 2009
    Last Update Posted:
    Sep 30, 2021
    Last Verified:
    Sep 1, 2021
    Keywords provided by Ideal Implant Incorporated
    breast implants
    saline

    Study Results

    No Results Posted as of Sep 30, 2021