NCT00858052

Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants

Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants in Women Who Are Undergoing Primary Breast Augmentation or Replacement of Existing Augmentation Implants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Ideal Implant Incorporated · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants.

Detailed description

For complete information about the clinical trial, see link in the reference section.

Conditions

• Breast Implants

Interventions

Type	Name	Description
DEVICE	Saline-filled breast implant [IDEAL IMPLANT (R)]	Breast augmentation

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-02-01
• Completion: 2021-05-01
• First posted: 2009-03-09
• Last updated: 2021-09-30

Locations

24 sites across 1 country: United States