Breast AugmentationNCT02905617
Post Market Clinical Experience Study of Sientra 207 Breast Implants
An observational study of Breast Augmentation and Breast Revision-Augmentation, run by Tiger Biosciences, LLC. at 1 site in United States.
Trial summary
A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants Read more about this study
- Who is it for?
- Ages 22 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation, Breast Revision-Augmentation
- What is being tested?
- Sientra 207 Silicone Gel Breast Implant
- Type of treatment
- Medical device
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 15 Jul 2020
- Phase
- Observational
- 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 22 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who receive Sientra Silicone 207 Gel Breast Implants for primary augmentation or revision augmentation
Who may be able to join
- Is a candidate for primary or revision breast augmentation and is at least 22 years of age,
- Agrees to Sientra study requirements and to comply with office follow-up visits at months 3, 6 and 12.
Who cannot join
- Does not meet the Investigator's standard eligibility for breast augmentation or revision surgery
- Surgeon is planning to use acellular dermal matrix (ADM) or surgical mesh and/or recommend postoperative massage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Market Clinical Experience Study of the Sientra 207 High-Strength Cohesive Plus (HSC+) Breast Implants in Primary and Revision Augmentation Participants
A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants
Read the detailed description
This study is designed to prospectively collect surgeon and participant satisfaction with the Sientra 207 implants in primary and revision augmentation participants over a 12-month time frame.
- Conditions
- Breast Augmentation, Breast Revision-Augmentation
- Being tested
- Sientra 207 Silicone Gel Breast Implant
- Keywords
- Breast Augmentation, Breast Revision-Augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sientra 207 Silicone Gel Breast ImplantDevice
The Sientra 207 Silicone Gel Breast Implant is a textured, round device with high-strength cohesive plus (HSC+) silicone gel fill.
| Study group | Role | What they receive |
|---|---|---|
| Primary Augmentation | Subjects undergoing general breast enlargement receiving Sientra Style 207 Silicone Gel Breast Implant. Receives: Device: Sientra 207 Silicone Gel Breast Implant | |
| Revision Augmentation | Subjects undergoing revision surgery with Sientra Style 207 Silicone Gel Breast Implant to revise or improve the result of a primary breast augmentation surgery. Receives: Device: Sientra 207 Silicone Gel Breast Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Overall Satisfaction Questionnaire
The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.
Measured: 3 months
Investigator Overall Satisfaction Questionnaire
The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.
Measured: 6 months
Investigator Overall Satisfaction Questionnaire
The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Why it stopped: Low enrollment
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiger Biosciences, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sientra, Inc., Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905617
- Sponsor's protocol ID
- CP-1008
- Status last verified
- Apr 2023
- First submitted
- 9 Sep 2016
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schwartz MR, Haws MJ, Phillips G. Results of the Postmarket Clinical Study of the Sientra 207 Highly Cohesive Gel Breast Implants in Primary and Revision Augmentation. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):40S-48S. doi: 10.1097/PRS.0000000000004353.
PubMed 29595717
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Experience Study of the Sientra 207 High-Strength Cohesive Plus (HSC+) Breast Implants in Primary and Revision Augmentation Participants
- ClinicalTrials.gov ID
- NCT02905617
- Acronym / sponsor ID
- CP-1008
- Conditions
- Breast Augmentation, Breast Revision-Augmentation
- Keywords
- Breast Augmentation, Breast Revision-Augmentation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Tiger Biosciences, LLC.Industry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 19 Sep 2016 (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.
A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants
Detailed description
This study is designed to prospectively collect surgeon and participant satisfaction with the Sientra 207 implants in primary and revision augmentation participants over a 12-month time frame.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Augmentation | – | Device: Sientra 207 Silicone Gel Breast ImplantSubjects undergoing general breast enlargement receiving Sientra Style 207 Silicone Gel Breast Implant. |
| Revision Augmentation | – | Device: Sientra 207 Silicone Gel Breast ImplantSubjects undergoing revision surgery with Sientra Style 207 Silicone Gel Breast Implant to revise or improve the result of a primary breast augmentation surgery. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who receive Sientra Silicone 207 Gel Breast Implants for primary augmentation or revision augmentation
Key inclusion criteria (2 listed)
- Is a candidate for primary or revision breast augmentation and is at least 22 years of age,
- Agrees to Sientra study requirements and to comply with office follow-up visits at months 3, 6 and 12.
Key exclusion criteria (2 listed)
- Does not meet the Investigator's standard eligibility for breast augmentation or revision surgery
- Surgeon is planning to use acellular dermal matrix (ADM) or surgical mesh and/or recommend postoperative massage.
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 |
|---|---|---|
| Sientra 207 Silicone Gel Breast ImplantThe Sientra 207 Silicone Gel Breast Implant is a textured, round device with high-strength cohesive plus (HSC+) silicone gel fill. | Device | Primary Augmentation, Revision Augmentation |
Primary outcome
Investigator Overall Satisfaction Questionnaire
Time frame: 3 months
The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.
Investigator Overall Satisfaction Questionnaire
Time frame: 6 months
The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.
Investigator Overall Satisfaction Questionnaire
Time frame: 12 months
The primary outcome measure of the study is to obtain the Investigator Overall Satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Results publication: PubMed 29595717Schwartz MR, Haws MJ, Phillips G. Results of the Postmarket Clinical Study of the Sientra 207 Highly Cohesive Gel Breast Implants in Primary and Revision Augmentation. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):40S-48S. doi: 10.1097/PRS.0000000000004353.
- 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.
Sientra, Inc. study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Augmentation and Breast Revision-Augmentation, 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 Jul 2023. 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?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Investigator Overall Satisfaction Questionnaire (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT02905617, 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 3 Jul 2023.