Recurrent Ptosis of the BreastSeriSupportNCT02016612
Seri Surgical Scaffold Support of the Lower Pole of the Breast
A study testing Seri Surgical Scaffold in people with Recurrent Ptosis of the Breast, run by Bengtson Center at 2 sites in United States.
Trial summary
Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be measured manually as well as percent of… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Ptosis of the Breast
- What is being tested?
- Seri Surgical Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to 30 Nov 2016
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age =>18 years
- requesting procedure
- No active cancer or infection
Who cannot join
- Known allergy to silk
- Pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bengtson Center for Aesthetics and Plastic Surgery
Grand Rapids, Michigan, 49503
Center for Aesthetics and Plastic Surgery
Grand Rapids, Michigan, 49503
About this study
Official title: Seri Surgical Scaffold (TM) Support of the Lower Pole of the Breasts in Augmentation Mastopexy or Breast Reduction Patients
Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D Imaging system reporting the amount of breast tissue above and below the nipple level.
Read the detailed description
Patients having augmentation mastopexy or breast reduction will be informed about Seri Scaffold and allowed to have Seri support included in their surgery or not. If the choose the scaffold will be placed under the skin in the lower pole of the breast as an internal hammock to help take weight off of the breast and potentially help prevent future stretch of the lower pole.
- Conditions
- Recurrent Ptosis of the Breast
- Being tested
- Seri Surgical Scaffold
- Keywords
- Recurrent, Ptosis, Reduction, Mammoplasty, Mastopexy
- Medical subject headings
- Recurrence, Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seri Surgical ScaffoldDevice
Also called Seri, Seri Scaffold
An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
| Study group | Role | What they receive |
|---|---|---|
| Reduction, Mastopexy No Implant, No Seri | Active comparator | Patients undergoing reduction or mastopexy but no implant is used and no Seri Surgical Scaffold support is used Receives: Device: Seri Surgical Scaffold |
| Mastopexy, Implant no Seri Scaffold | Active comparator | Mastopexy with implant, No Seri Surgical Scaffold support is used Receives: Device: Seri Surgical Scaffold |
| Breast Reduction with Seri Support | Active comparator | Patients undergoing breast reduction with the use of Seri Surgical scaffold support Receives: Device: Seri Surgical Scaffold |
| Augmentation Mastopexy, Implant and Seri | Active comparator | Augmentation Mastopexy patients where Seri Surgical scaffold is used Receives: Device: Seri Surgical Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple to Fold Measurement on Stretch
The Nipple to fold will be measured manually over time to 1 year
Measured: 1 year post op
Secondary outcomes (1)
Percent Breast Tissue Above Nipple
The percentage of breast tissue above and below the horizontal plane of the nipple over time
Measured: 1 year post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2015
- Study completion30 Nov 2016
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.
- Other trials for Recurrent Ptosis of the BreastStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bengtson Center
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan Medical
- Responsible party
- Principal investigator, Bradley Bengtson, M.D., Bengtson Center
- Investigators
- Bradley P Bengtson, MD, Principal investigator, Bengtson Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016612
- Sponsor's protocol ID
- 007
- Acronym
- SeriSupport
- Status last verified
- Jan 2018
- First submitted
- 16 Dec 2013
- Last updated
- 13 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seri Surgical Scaffold (TM) Support of the Lower Pole of the Breasts in Augmentation Mastopexy or Breast Reduction Patients
- ClinicalTrials.gov ID
- NCT02016612
- Acronym / sponsor ID
- SeriSupport / 007
- Conditions
- Recurrent Ptosis of the Breast
- Keywords
- Recurrent, Ptosis, Reduction, Mammoplasty, Mastopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bengtson CenterUniversity, hospital or other
- Collaborators
- Allergan Medical
- Study start
- Oct 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Posted 13 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D Imaging system reporting the amount of breast tissue above and below the nipple level.
Detailed description
Patients having augmentation mastopexy or breast reduction will be informed about Seri Scaffold and allowed to have Seri support included in their surgery or not. If the choose the scaffold will be placed under the skin in the lower pole of the breast as an internal hammock to help take weight off of the breast and potentially help prevent future stretch of the lower pole.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reduction, Mastopexy No Implant, No Seri | Active comparator | Device: Seri Surgical ScaffoldPatients undergoing reduction or mastopexy but no implant is used and no Seri Surgical Scaffold support is used |
| Mastopexy, Implant no Seri Scaffold | Active comparator | Device: Seri Surgical ScaffoldMastopexy with implant, No Seri Surgical Scaffold support is used |
| Breast Reduction with Seri Support | Active comparator | Device: Seri Surgical ScaffoldPatients undergoing breast reduction with the use of Seri Surgical scaffold support |
| Augmentation Mastopexy, Implant and Seri | Active comparator | Device: Seri Surgical ScaffoldAugmentation Mastopexy patients where Seri Surgical scaffold is used |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age =>18 years
- requesting procedure
- No active cancer or infection
Key exclusion criteria (2 listed)
- Known allergy to silk
- Pregnant or lactating
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 |
|---|---|---|
| Seri Surgical ScaffoldAlso: Seri, Seri ScaffoldAn FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. | Device | Augmentation Mastopexy, Implant and Seri, Breast Reduction with Seri Support, Mastopexy, Implant no Seri Scaffold, Reduction, Mastopexy No Implant, No Seri |
Primary outcome
Nipple to Fold Measurement on Stretch
Time frame: 1 year post op
The Nipple to fold will be measured manually over time to 1 year
1 secondary outcome
Percent Breast Tissue Above Nipple
Time frame: 1 year post op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Bradley P Bengtson, MD principal investigator
Bengtson Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seri Surgical Scaffold in people with Recurrent Ptosis of the Breast, run by Bengtson Center at 2 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 3 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: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 13 Feb 2018). 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?
Nipple to Fold Measurement on Stretch (time frame: 1 year post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2018.