AzTrials
AzTrials

Breast ImplantationRANBI-INCT02438332

Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants

An observational study of Breast Implantation, run by Allergan at 17 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 22 years and older, women only
Conditions the study is for
Breast Implantation
What is being tested?
Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants, Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants and Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants
Type of treatment
Medical device
How many people
330 participants
Where
17 sitesCanada
Study dates
Dec 2014to Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Canada17 sites

  • Banff Plastic Surgery

    Banff, Alberta, T1L 1B7

  • Centre de Medecine et de Chirurgie Ambulatoires Isomed

    Boucherville, Quebec, J4B 7M6

  • Macleod Trail Plastic Surgery

    Calgary, Alberta, T2H 0L8

  • Jonathan Toy

    Edmonton, Alberta, T5M 327

  • Y.E.S MedSpa & Cosmetic Surgery Centre

    Langley, British Columbia, V2Y 0C8

  • CCPEM

    Montreal, Quebec, H3G 1B9

  • Institute of Cosmetic and Laser Surgery

    Oakville, Ontario, L6J 7W5

  • Ottawa Plastic Surgery: Dr. Howard Silverman

    Ottawa, Ontario, K1Z 8R9

  • Cosmedica

    Pointe-Claire, Quebec, H9R 5N3

  • Clinique de Chirurgie Plastique et Esthétique de la Haute-Ville

    Québec, Quebec, G1V 1R4

  • Sebastien Nguyen MD Inc.

    Québec, Quebec, G1V 4M6

  • Rice Cosmetic Surgery

    Toronto, Ontario, M2J 1V1

  • Cosmedical Rejuvenation Clinic

    Toronto, Ontario, M2P 2C2

  • Yorkville Institute of Plastic Surgery

    Toronto, Ontario, M5R 2J3

  • SpaSurgica

    Waterloo, Ontario, N2J 1M3

  • Cosmetic Surgery Clinic

    Waterloo, Quebec, N2L 3S2

  • Sandra McGill MD Inc.

    Westmount, Quebec, H3Z 1S3

Other trials in Canada

About this study

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.

Being tested
Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants, Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants, Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast ImplantsDevice

    Also called Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

    Surgical implant

  • Textured NATRELLE® INSPIRA® TruForm® 1 Breast ImplantsDevice

    Also called Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

    surgical implant

  • Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast ImplantsDevice

    Also called Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

    surgical implant

  • Textured NATRELLE® INSPIRA® TruForm® 1 Breast ImplantsDevice

    Also called Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

    surgical implant

Study groups in NCT02438332
Study groupRoleWhat they receive
NATRELLE® INSPIRA® TruForm® 1 (Smooth)Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 1 breast implants
Receives: 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
Receives: 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
Receives: 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
Receives: Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 4 Years

Secondary outcomes (6)

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

    Measured: 4 Years

  2. Reasons For Primary Augmentation

    Measured: 4 Years

  3. Time From the Date of Implant Until First Reoperation

    Measured: 4 Years

  4. Reasons For Reoperation Incidence

    Measured: 4 Years

  5. Incidences of Implant Removal With Replacement

    Measured: 4 Years

  6. Incidences of Implant Removal Without Replacement

    Measured: 4 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02438332
Sponsor's protocol ID
GMA-CAN-PLS-0337
Acronym
RANBI-I
Status last verified
Jul 2016
First submitted
6 May 2015
Last updated
25 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Implantation, run by Allergan at 17 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants (time frame: 4 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02438332.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in