Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

October 6, 2014 updated by: Allergan Medical
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84329

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate.
  • Females seeking revision augmentation or revision reconstruction, where problems exist
  • Have any of the following conditions or situations present:
  • Post mastectomy surgical removal of the breast for cancer or other disease;
  • Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity;
  • Severe ptosis requiring reconstruction;
  • Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity.
  • Adequate tissue available to cover implants.
  • Saline-filled implants are not an appropriate choice.

Exclusion Criteria:

  • Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
  • Existing carcinoma of the breast, without mastectomy.
  • Abscess of infection in the body at the time of enrollment.
  • Pregnant or nursing.
  • Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
  • Show tissue characteristics which are clinically incompatible with mammaplasty.
  • Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk.
  • Are not willing to undergo further surgery for revision, if medically required.
  • Diagnosis of lupus or scleroderma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3
Revision-augmentation
Device: Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery
Experimental: 1
Primary reconstruction
Device: Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery
Experimental: 2
Revision-reconstruction
Device: Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Complications
Time Frame: 5 years
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
Time Frame: 5 years
Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1997

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

October 13, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 910044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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