Breast ImplantsNCT00858052
Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants
A study testing Saline-filled breast implant [IDEAL IMPLANT (R)] in people with Breast Implants, run by Ideal Implant Incorporated at 24 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implants
- What is being tested?
- Saline-filled breast implant [IDEAL IMPLANT (R)]
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 24 sitesUnited States
- Study dates
- Feb 2009to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilateral primary breast augmentation-dissatisfaction with breast size
- Bilateral replacement augmentation-has had previous silicone saline-filled or gel-filled breast implants
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Study site
Allen, Texas
Study site
Beverly Hills, California
Study site
Boca Raton, Florida
Study site
Boynton Beach, Florida
Study site
Dallas, Texas
Study site
Duluth, Georgia
Study site
Folsom, California
Study site
Fort Lauderdale, Florida
Study site
Hollywood, Florida
Study site
Houston, Texas
Study site
Huntington Beach, California
Study site
Irving, Texas
Study site
Jacksonville, Florida
Study site
Loxahatchee Groves, Florida
Study site
Marietta, Georgia
Study site
Miami, Florida
Study site
Modesto, California
Study site
Ponte Vedra Beach, Florida
Study site
Riverside, California
Study site
Roswell, Georgia
Study site
Sacramento, California
Study site
Santa Monica, California
Study site
Southlake, Texas
Study site
Stockton, California
About this study
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
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.
Read the detailed description
For complete information about the clinical trial, see link in the reference section.
- Conditions
- Breast Implants
- Being tested
- Saline-filled breast implant [IDEAL IMPLANT (R)]
- Keywords
- breast implants, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline-filled breast implant [IDEAL IMPLANT (R)]Device
Also called IDEAL IMPLANT (R) Saline-filled Breast Implant
Breast augmentation
| Study group | Role | What they receive |
|---|---|---|
| breast augmentation | Experimental | breast implant Receives: Device: Saline-filled breast implant [IDEAL IMPLANT (R)] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2012
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ideal Implant Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858052
- Sponsor's protocol ID
- G 080055
- Status last verified
- Sep 2021
- First submitted
- 5 Mar 2009
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Nichter LS, Hardesty RA, Anigian GM. IDEAL IMPLANT Structured Breast Implants: Core Study Results at 6 Years. Plast Reconstr Surg. 2018 Jul;142(1):66-75. doi: 10.1097/PRS.0000000000004460.
PubMed 29489559
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00858052
- Acronym / sponsor ID
- G 080055
- Conditions
- Breast Implants
- Keywords
- breast implants, saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ideal Implant IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2009 (actual)
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast augmentation | Experimental | Device: Saline-filled breast implant [IDEAL IMPLANT (R)]breast implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bilateral primary breast augmentation-dissatisfaction with breast size
- Bilateral replacement augmentation-has had previous silicone saline-filled or gel-filled breast implants
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline-filled breast implant [IDEAL IMPLANT (R)]Also: IDEAL IMPLANT (R) Saline-filled Breast ImplantBreast augmentation | Device | breast augmentation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Derived from this study: PubMed 29489559Nichter LS, Hardesty RA, Anigian GM. IDEAL IMPLANT Structured Breast Implants: Core Study Results at 6 Years. Plast Reconstr Surg. 2018 Jul;142(1):66-75. doi: 10.1097/PRS.0000000000004460.
- Click here for more information about study: "Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast ImplantsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline-filled breast implant [IDEAL IMPLANT (R)] in people with Breast Implants, run by Ideal Implant Incorporated at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.