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

Sponsored by:	Ideal Implant Incorporated
Information provided by:	Ideal Implant Incorporated
ClinicalTrials.gov Identifier:	NCT00858052

Purpose

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.

Condition	Intervention
Breast Augmentation	Device: Saline-filled breast implant [IDEAL IMPLANT (R)]

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Breast Reconstruction

U.S. FDA Resources

Further study details as provided by Ideal Implant Incorporated:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Breast Implant: Experimental	Device: Saline-filled breast implant [IDEAL IMPLANT (R)] Breast augmentation

Detailed Description:

For complete information about the clinical trial, see www.idealimplant.com

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858052

Contacts

Contact: Robert S Hamas, MD

info@idealimplant.com

Locations

United States, California
	Recruiting
Santa Monica, California, United States
Contact: Charlotta La Via, MD
Principal Investigator: Charlotta La Via, MD
	Recruiting
Huntington Beach, California, United States
Contact: Jed H Horowitz, MD
Principal Investigator: Jed H Horowitz, MD
	Recruiting
Huntington Beach, California, United States
Contact: Larry S Nichter, MD
Principal Investigator: Larry S Nichter, MD
	Recruiting
Riverside, California, United States
Contact: Robert A Hardesty, MD
Principal Investigator: Robert A Hardesty, MD
	Recruiting
Beverly Hills, California, United States
Contact: Jay Calvert, MD
Principal Investigator: Jay Calvert, MD
	Recruiting
Beverly Hills, California, United States
Contact: Jon A Perlman, MD
Principal Investigator: Jon A Perlman, MD
	Recruiting
Beverly Hills, California, United States
Contact: Nicholas Nikolov, MD
Principal Investigator: Nicholas Nikolov, MD
United States, Florida
	Recruiting
Weston, Florida, United States
Contact: Charles A Messa, MD
Principal Investigator: Charles A Messa, MD
	Recruiting
Boca Raton, Florida, United States
Contact: Steven Schuster, MD
Principal Investigator: Steven Schuster, MD
	Recruiting
Ft. Lauderdale, Florida, United States
Contact: C. R Palma, MD
Principal Investigator: C. R Palma, MD
	Recruiting
Boynton Beach, Florida, United States
Contact: David A Rosenstein, MD
Principal Investigator: David A Rosenstein, MD
	Recruiting
Hollywood, Florida, United States
Contact: Yoav Barnavon, MD
Principal Investigator: Yoav Barnavon, MD
United States, Georgia
	Recruiting
Marietta, Georgia, United States
Contact: James E Leake, MD
Principal Investigator: James E Leake, MD
	Recruiting
Marietta, Georgia, United States
Contact: Michael Petrosky, MD
Principal Investigator: Michael Petrosky, MD
	Recruiting
Duluth, Georgia, United States
Contact: Phillip H Nakano, MD
Principal Investigator: Phillip H Nakano, MD
	Recruiting
Roswell, Georgia, United States
Contact: Miles H Graivier, MD
Principal Investigator: Miles H Graivier, MD
	Recruiting
Marietta, Georgia, United States
Contact: Michael J McNeel, MD
Principal Investigator: Michael J McNeel, MD
	Recruiting
Marietta, Georgia, United States
Contact: D. K West, MD
Principal Investigator: D. K West, MD
United States, Texas
	Active, not recruiting
Dallas, Texas, United States
	Recruiting
Houston, Texas, United States
Contact: Bonnie Baldwin, MD
Principal Investigator: Bonnie Baldwin, MD
	Recruiting
Houston, Texas, United States
Contact: Robert D Peterson, MD
Principal Investigator: Robert D Peterson, MD
	Recruiting
Houston, Texas, United States
Contact: Henry A Mentz, MD
Principal Investigator: Henry A Mentz, MD
	Recruiting
Houston, Texas, United States
Contact: Christopher Patronella, MD
Principal Investigator: Christopher Patronella, MD
	Recruiting
Houston, Texas, United States
Contact: German Newall, MD
Principal Investigator: German Newall, MD
	Active, not recruiting
Dallas, Texas, United States

Sponsors and Collaborators

Ideal Implant Incorporated

More Information

Additional Information:

Click here for more information about study: "Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ideal Implant Incorporated ( Robert S Hamas, President )
Study ID Numbers:	G 080055
Study First Received:	March 5, 2009
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00858052 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ideal Implant Incorporated:

Determine safety and effectiveness of the IDEAL IMPLANT(R) Saline-filled Breast Implant

ClinicalTrials.gov processed this record on September 11, 2009