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

Breast Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858052
• Other study ID #: G 080055
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: May 2021

Study information

• Verified date: September 2021
• Source: Ideal Implant Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2021
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Bilateral primary breast augmentation-dissatisfaction with breast size

• Bilateral replacement augmentation-has had previous silicone saline-filled or gel-filled breast implants

Exclusion Criteria:

• Diagnosis of active cancer of any type

• Has ever been diagnosed with breast cancer

• Has pre-malignant breast disease

• Has tissue characteristics incompatible with an implant

• Has unrealistic or unreasonable expectations of the procedure results

Related Conditions & MeSH terms

• Breast Implants

Intervention

Device:
• Saline-filled breast implant [IDEAL IMPLANT (R)]
Breast augmentation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ideal Implant Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs.

External Links

•   Click here for more information about study: "Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants