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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691327
• Other study ID #: 910044
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: October 6, 2014
• Start date: December 1997
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84329
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Device:
• Natrelle(TM) Silicone-Filled Breast Implants
Breast implant surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Complications	By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts	5 years	Yes
Secondary	Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale	Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied	5 years	No