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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Allergan Medical

ClinicalTrials.gov Identifier:

NCT00691327

First received: June 3, 2008

Last updated: December 12, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 3, 2008
Last Updated Date	December 12, 2012
Start Date ^ICMJE	December 1997
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 4, 2008)	Local complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00691327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 4, 2008)	Satisfaction determined by patients and physicians [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Official Title ^ICMJE	Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Brief Summary	Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Breast Reconstruction
Intervention ^ICMJE	Device: Natrelle(TM) Silicone-Filled Breast Implants Breast implant surgery
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	83091
Estimated Completion Date	December 2012
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00691327
Other Study ID Numbers ^ICMJE	910044
Has Data Monitoring Committee	No
Responsible Party	Allergan Medical
Study Sponsor ^ICMJE	Allergan Medical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Allergan Medical
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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