Breast AugmentationNCT00905645
Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
A study testing Silimed Gel-Filled Mammary Implant in people with Breast Augmentation and Breast Reconstruction, run by Tiger Biosciences, LLC. at 1 site in United States.
Trial summary
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Augmentation, Breast Reconstruction, Breast Revision
- What is being tested?
- Silimed Gel-Filled Mammary Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,788 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are admitted into the study only if all of the following eligibility is true:
- Female
- Age limitation specific to the indication:
- Primary Augmentation: Must be 18 years or older
- Primary Reconstruction: No age limit
- Revision: If original surgery was primary reconstruction, then no age limit. If original surgery was primary augmentation, then must be 18 years or older.
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- Adequate tissue available to cover implant(s)
- Willingness to follow study requirements (informed consent form, follow-up visits)
- Candidate for primary augmentation, primary reconstruction, or revision
Who cannot join
- Subjects are not eligible if any of the following criteria exist:
- Advanced fibrocystic disease, considered to be pre-malignant without mastectomy
- Inadequate or unsuitable tissue
- Active infection in the body at the time of surgery
- Pregnant or lactating
- Medical condition that might result in unduly high surgical risk and/or significant postoperative complications, in the judgment of the Investigator
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- Use of drugs, including any drug that would interfere with blood clotting, that might result in high risk and/or significant postoperative complications
- Demonstrated psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure
- Determination by physical examination that the subject does have any connective tissue/autoimmune disorder
- Existing carcinoma of the breast without accompanying mastectomy
- MRI scan is prohibited because of implanted metal device, claustrophobia, or other condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Being tested
- Silimed Gel-Filled Mammary Implant
- Keywords
- Breast Augmentation, Breast Reconstruction, Breast Revision, Silicone breast implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silimed Gel-Filled Mammary ImplantDevice
| Study group | Role | What they receive |
|---|---|---|
| Primary Augmentation | Experimental | Silimed Gel-Filled Mammary Implant Receives: Device: Silimed Gel-Filled Mammary Implant |
| Revision-Augmentation | Experimental | Silimed Gel-Filled Mammary Implant Receives: Device: Silimed Gel-Filled Mammary Implant |
| Primary Reconstruction | Experimental | Silimed Gel-Filled Mammary Implant Receives: Device: Silimed Gel-Filled Mammary Implant |
| Revision-Reconstruction | Experimental | Silimed Gel-Filled Mammary Implant Receives: Device: Silimed Gel-Filled Mammary Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Complications
Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.
Measured: 10 Years
Secondary outcomes (1)
Satisfaction Determined by Patients
Assessment of the effectiveness of Study Implants based on patient satisfaction using a 5-point scale where 1=strongly agree to 5= strongly disagree. The patient satisfaction measures through 10 years provided in the table below are based on questionnaire responses of "Strongly Agree" and "Agree."
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startNov 2002
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast AugmentationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,788 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiger Biosciences, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denise Dajles, PhD, Study director, Tiger Biosciences, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905645
- Sponsor's protocol ID
- G010193
- Status last verified
- Sep 2023
- First submitted
- 18 May 2009
- Last updated
- 11 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stevens WG, Harrington J, Alizadeh K, Berger L, Broadway D, Hester TR, Kress D, d'Incelli R, Kuhne J, Beckstrand M. Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. Food and Drug Administration-approved Silimed(R) brand round and shaped implants with high-strength silicone gel. Plast Reconstr Surg. 2012 Nov;130(5):973-981. doi: 10.1097/PRS.0b013e31826b7d2f.
PubMed 23096598Stevens WG, Harrington J, Alizadeh K, Broadway D, Zeidler K, Godinez TB. Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel. Aesthet Surg J. 2015 May;35 Suppl 1:S3-10. doi: 10.1093/asj/sjv020.
PubMed 25948657Stevens WG, Calobrace MB, Harrington J, Alizadeh K, Zeidler KR, d'Incelli RC. Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel. Aesthet Surg J. 2016 Apr;36(4):404-16. doi: 10.1093/asj/sjw015.
PubMed 26961987Stevens WG, Calobrace MB, Alizadeh K, Zeidler KR, Harrington JL, d'Incelli RC. Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):7S-19S. doi: 10.1097/PRS.0000000000004350.
PubMed 29595714
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation
- ClinicalTrials.gov ID
- NCT00905645
- Acronym / sponsor ID
- G010193
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Keywords
- Breast Augmentation, Breast Reconstruction, Breast Revision, Silicone breast implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,788 participants (actual)
- Lead sponsor
- Tiger Biosciences, LLC.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 May 2009 (estimated)
- Results
- Posted 11 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary Augmentation | Experimental | Device: Silimed Gel-Filled Mammary ImplantSilimed Gel-Filled Mammary Implant |
| Revision-Augmentation | Experimental | Device: Silimed Gel-Filled Mammary ImplantSilimed Gel-Filled Mammary Implant |
| Primary Reconstruction | Experimental | Device: Silimed Gel-Filled Mammary ImplantSilimed Gel-Filled Mammary Implant |
| Revision-Reconstruction | Experimental | Device: Silimed Gel-Filled Mammary ImplantSilimed Gel-Filled Mammary Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- Age limitation specific to the indication:
- Adequate tissue available to cover implant(s)
- Willingness to follow study requirements (informed consent form, follow-up visits)
- Candidate for primary augmentation, primary reconstruction, or revision
Key exclusion criteria (11 listed)
- Advanced fibrocystic disease, considered to be pre-malignant without mastectomy
- Inadequate or unsuitable tissue
- Active infection in the body at the time of surgery
- Pregnant or lactating
- Medical condition that might result in unduly high surgical risk and/or significant postoperative complications, in the judgment of the Investigator
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 |
|---|---|---|
| Silimed Gel-Filled Mammary Implant | Device | Primary Augmentation, Primary Reconstruction, Revision-Augmentation, Revision-Reconstruction |
Primary outcome
Local Complications
Time frame: 10 Years
Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.
1 secondary outcome
Satisfaction Determined by Patients
Time frame: 10 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23096598Stevens WG, Harrington J, Alizadeh K, Berger L, Broadway D, Hester TR, Kress D, d'Incelli R, Kuhne J, Beckstrand M. Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. Food and Drug Administration-approved Silimed(R) brand round and shaped implants with high-strength silicone gel. Plast Reconstr Surg. 2012 Nov;130(5):973-981. doi: 10.1097/PRS.0b013e31826b7d2f.
- Background: PubMed 25948657Stevens WG, Harrington J, Alizadeh K, Broadway D, Zeidler K, Godinez TB. Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel. Aesthet Surg J. 2015 May;35 Suppl 1:S3-10. doi: 10.1093/asj/sjv020.
- Background: PubMed 26961987Stevens WG, Calobrace MB, Harrington J, Alizadeh K, Zeidler KR, d'Incelli RC. Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel. Aesthet Surg J. 2016 Apr;36(4):404-16. doi: 10.1093/asj/sjw015.
- Background: PubMed 29595714Stevens WG, Calobrace MB, Alizadeh K, Zeidler KR, Harrington JL, d'Incelli RC. Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):7S-19S. doi: 10.1097/PRS.0000000000004350.
- Individual participant dataSharing planned: No
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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.
Denise Dajles, PhD study director
Tiger Biosciences, LLC.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silimed Gel-Filled Mammary Implant in people with Breast Augmentation and Breast Reconstruction, run by Tiger Biosciences, LLC. at 1 site 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 9 inclusion and 11 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 11 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Local Complications (time frame: 10 Years). 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 NCT00905645, which also lists 4 linked publications.
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 11 Jan 2024.