Expired Study
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Indianapolis, Indiana


Purpose:

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.


Criteria:

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 is Available At:


Original ID:

910044


NCT ID:

NCT00691327


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Allergan Medical


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

83091


Enrollment Type:

Actual


Study Dates

Start Date:December 1997
Completion Date:December 2012
Completion Type:Actual
Primary Completion Date:December 2012
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 4, 2013
First Received Date:June 3, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Local complications
Time Frame:5 years
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Satisfaction determined by patients and physicians
Time Frame:5 years
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Natrelle(TM) Silicone-Filled Breast Implants
Description:Breast implant surgery
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Primary reconstruction
Study Arm Type:Experimental
Arm Name:2
Description:Revision-reconstruction
Study Arm Type:Experimental
Arm Name:3
Description:Revision-augmentation

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Allergan Medical

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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