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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691327
First Posted: June 5, 2008
Last Update Posted: October 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
June 3, 2008
June 5, 2008
December 30, 2013
February 12, 2014
October 13, 2014
December 1997
December 2012   (Final data collection date for primary outcome measure)
Local Complications [ Time Frame: 5 years ]
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Local Complications [ Time Frame: 5 years ]
Complete list of historical versions of study NCT00691327 on ClinicalTrials.gov Archive Site
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
Satisfaction determined by patients and physicians [ Time Frame: 5 years ]
Not Provided
Not Provided
 
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Breast Reconstruction
Device: Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery
  • Experimental: 1
    Primary reconstruction
    Intervention: Device: Natrelle(TM) Silicone-Filled Breast Implants
  • Experimental: 2
    Revision-reconstruction
    Intervention: Device: Natrelle(TM) Silicone-Filled Breast Implants
  • Experimental: 3
    Revision-augmentation
    Intervention: Device: Natrelle(TM) Silicone-Filled Breast Implants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84329
December 2012
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00691327
910044
No
Not Provided
Not Provided
Allergan ( Allergan Medical )
Allergan Medical
Not Provided
Not Provided
Allergan
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP