Skip to main content
OpenTrials
Completed

NCT Number: NCT02438332

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Implantation

Age range

22 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Banff Plastic Surgery, Banff, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants

Device

Surgical implant

Other names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants

Device

surgical implant

Other names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants

Device

surgical implant

Other names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

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

    Time frame: 4 Years

Secondary outcomes

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

    Time frame: 4 Years

  2. Reasons For Primary Augmentation

    Time frame: 4 Years

  3. Time From the Date of Implant Until First Reoperation

    Time frame: 4 Years

  4. Reasons For Reoperation Incidence

    Time frame: 4 Years

  5. Incidences of Implant Removal With Replacement

    Time frame: 4 Years

  6. Incidences of Implant Removal Without Replacement

    Time frame: 4 Years

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Acronym: RANBI-I

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 8, 2015
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.