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RANBI-I: Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT02438332
Collaborator
(none)
330
Enrollment
17
Locations
18
Duration (Months)
19.4
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.

Condition or Disease Intervention/Treatment Phase
  • Device: Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants
  • Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants
  • Device: Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants
  • Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants

Study Design

Study Type:
Observational
Actual Enrollment :
330 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
NATRELLE® INSPIRA® TruForm® 1 (Smooth)

Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 1 breast implants

Device: Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants
Surgical implant
Other Names:
  • Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

    		•
    NATRELLE® INSPIRA® TruForm® 1 (Textured)

    Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 1 breast implants

    Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants
    surgical implant
    Other Names:
  • Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

    		•
    NATRELLE® INSPIRA® TruForm® 2 (Smooth)

    Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 2 breast implants

    Device: Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants
    surgical implant
    Other Names:
  • Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

    		•
    NATRELLE® INSPIRA® TruForm® 2 (Textured)

    Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 2 breast implants

    Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants
    surgical implant
    Other Names:
  • Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants [4 Years]

    Secondary Outcome Measures

    1. Incidence (by Product Type) of First Reoperation Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm®1 or TruForm® 2 Breast Implants [4 Years]

    2. Reasons For Primary Augmentation [4 Years]

    3. Time From the Date of Implant Until First Reoperation [4 Years]

    4. Reasons For Reoperation Incidence [4 Years]

    5. Incidences of Implant Removal With Replacement [4 Years]

    6. Incidences of Implant Removal Without Replacement [4 Years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach smooth or textured NATRELLE® INSPIRA® TruForm® 1 or 2 device

    • Primary breast augmentation 2 to 4 years (24-48 months) prior to data collection

    • Subfascial, submuscular, dual plane or subglandular implant placement

    Exclusion Criteria:

    • Breast augmentation for Poland Syndrome or amastia

    • Breast reconstruction following mastectomy

    • Revision or secondary breast reconstruction

    • Non NATRELLE® INSPIRA® device implanted at initial breast augmentation

    • Women diagnosed with breast disease considered to be pre-malignant or malignant prior to or at the time of primary breast augmentation

    • Surgical procedures of the breast not related to the primary breast augmentation (e.g. excision of significant skin lesions or a biopsy) occurring prior to or at the time of primary augmentation that may adversely affect the aesthetic outcome in the opinion of the investigator

    • Axillary or peri-areolar approach

    • Mastopexy augmentation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banff Plastic Surgery Banff Alberta Canada T1L 1B7
    2 Macleod Trail Plastic Surgery Calgary Alberta Canada T2H 0L8
    3 Jonathan Toy Edmonton Alberta Canada T5M 327
    4 Y.E.S MedSpa & Cosmetic Surgery Centre Langley British Columbia Canada V2Y 0C8
    5 Institute of Cosmetic and Laser Surgery Oakville Ontario Canada L6J 7W5
    6 Ottawa Plastic Surgery: Dr. Howard Silverman Ottawa Ontario Canada K1Z 8R9
    7 Rice Cosmetic Surgery Toronto Ontario Canada M2J 1V1
    8 Cosmedical Rejuvenation Clinic Toronto Ontario Canada M2P 2C2
    9 Yorkville Institute of Plastic Surgery Toronto Ontario Canada M5R 2J3
    10 SpaSurgica Waterloo Ontario Canada N2J 1M3
    11 Centre de Medecine et de Chirurgie Ambulatoires Isomed Boucherville Quebec Canada J4B 7M6
    12 CCPEM Montreal Quebec Canada H3G 1B9
    13 Cosmedica Pointe-Claire Quebec Canada H9R 5N3
    14 Cosmetic Surgery Clinic Waterloo Quebec Canada N2L 3S2
    15 Sandra McGill MD Inc. Westmount Quebec Canada H3Z 1S3
    16 Clinique de Chirurgie Plastique et Esthétique de la Haute-Ville Quebec Canada G1V 1R4
    17 Sebastien Nguyen MD Inc. Quebec Canada G1V 4M6

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT02438332
    Other Study ID Numbers:
    • GMA-CAN-PLS-0337
    First Posted:
    May 8, 2015
    Last Update Posted:
    Jul 25, 2016
    Last Verified:
    Jul 1, 2016

    Study Results

    No Results Posted as of Jul 25, 2016