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

NCT00691327 | Completed Results

• 1 other identifier: 910044
• Study Type: interventional
• Target: 84,329
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Reconstruction

Keywords

Revision of augmentation or reconstruction

Outcome Measures

Primary Outcomes (1)

• Local Complications

  By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts

  5 years

Secondary Outcomes (1)

• Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale

  5 years

Study Arms (3)

1

EXPERIMENTAL

Primary reconstruction

Device: Natrelle(TM) Silicone-Filled Breast Implants

2

EXPERIMENTAL

Revision-reconstruction

Device: Natrelle(TM) Silicone-Filled Breast Implants

3

EXPERIMENTAL

Revision-augmentation

Device: Natrelle(TM) Silicone-Filled Breast Implants

Interventions

Natrelle(TM) Silicone-Filled Breast Implants DEVICE

Breast implant surgery

1; 2; 3

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan Medical: lead

Study Sites (1)

Unknown Facility

Indianapolis, Indiana, United States

Location

Results Point of Contact

• Title: Medical Monitor
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: December 1, 1997
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 13, 2014
• Results First Posted: February 12, 2014

Record last verified: 2013-12

Locations

US (1)