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

September 24, 2021 updated by: Ideal Implant Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States
      • Folsom, California, United States
      • Huntington Beach, California, United States
      • Modesto, California, United States
      • Riverside, California, United States
      • Sacramento, California, United States
      • Santa Monica, California, United States
      • Stockton, California, United States
    • Florida
      • Boca Raton, Florida, United States
      • Boynton Beach, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Loxahatchee Groves, Florida, United States
      • Miami, Florida, United States
      • Ponte Vedra Beach, Florida, United States
    • Georgia
      • Duluth, Georgia, United States
      • Marietta, Georgia, United States
      • Roswell, Georgia, United States
    • Texas
      • Allen, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Irving, Texas, United States
      • Southlake, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: breast augmentation
breast implant
Device: Saline-filled breast implant [IDEAL IMPLANT (R)]
Breast augmentation
Other Names:
  • IDEAL IMPLANT (R) Saline-filled Breast Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs.
2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ideal Implant Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • G 080055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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