NCT02438332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

May 6, 2015

Last Update Submit

July 22, 2016

Conditions

Breast Implantation

Outcome Measures

Primary Outcomes (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 Outcomes (6)

  • 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

  • Reasons For Primary Augmentation

    4 Years

  • Time From the Date of Implant Until First Reoperation

    4 Years

  • Reasons For Reoperation Incidence

    4 Years

  • Incidences of Implant Removal With Replacement

    4 Years

  • +1 more secondary outcomes

Study Arms (4)

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

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

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

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

Interventions

Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast ImplantsDEVICE

Surgical implant

Also known as: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)
NATRELLE® INSPIRA® TruForm® 1 (Smooth)
Textured NATRELLE® INSPIRA® TruForm® 1 Breast ImplantsDEVICE

surgical implant

Also known as: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)
NATRELLE® INSPIRA® TruForm® 1 (Textured)
Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast ImplantsDEVICE

surgical implant

Also known as: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)
NATRELLE® INSPIRA® TruForm® 2 (Smooth)

Eligibility Criteria

Age22 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects that have undergone a primary breast augmentation for aesthetic reasons with NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 implant.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Banff Plastic Surgery

Banff, Alberta, T1L 1B7, Canada

Location

Macleod Trail Plastic Surgery

Calgary, Alberta, T2H 0L8, Canada

Location

Jonathan Toy

Edmonton, Alberta, T5M 327, Canada

Location

Y.E.S MedSpa & Cosmetic Surgery Centre

Langley, British Columbia, V2Y 0C8, Canada

Location

Institute of Cosmetic and Laser Surgery

Oakville, Ontario, L6J 7W5, Canada

Location

Ottawa Plastic Surgery: Dr. Howard Silverman

Ottawa, Ontario, K1Z 8R9, Canada

Location

Rice Cosmetic Surgery

Toronto, Ontario, M2J 1V1, Canada

Location

Cosmedical Rejuvenation Clinic

Toronto, Ontario, M2P 2C2, Canada

Location

Yorkville Institute of Plastic Surgery

Toronto, Ontario, M5R 2J3, Canada

Location

SpaSurgica

Waterloo, Ontario, N2J 1M3, Canada

Location

Centre de Medecine et de Chirurgie Ambulatoires Isomed

Boucherville, Quebec, J4B 7M6, Canada

Location

CCPEM

Montreal, Quebec, H3G 1B9, Canada

Location

Cosmedica

Pointe-Claire, Quebec, H9R 5N3, Canada

Location

Clinique de Chirurgie Plastique et Esthétique de la Haute-Ville

Québec, Quebec, G1V 1R4, Canada

Location

Sebastien Nguyen MD Inc.

Québec, Quebec, G1V 4M6, Canada

Location

Cosmetic Surgery Clinic

Waterloo, Quebec, N2L 3S2, Canada

Location

Sandra McGill MD Inc.

Westmount, Quebec, H3Z 1S3, Canada

Location

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 8, 2015

Study Start

December 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 25, 2016

Record last verified: 2016-07

Locations

CA(17)