Breast ReconstructionNCT01914653
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction
A study testing Silk surgical mesh in people with Breast Reconstruction, run by Sofregen Medical, Inc. at 1 site in Israel.
Trial summary
Prospective, single center, postmarket clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Silk surgical mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2013to Mar 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for enrollment, the subject must:
- Be female, ≥ 18 years of age
- If the subject is a female of childbearing potential, have a pregnancy test evaluated as negative prior to surgery, per the site's standard of care
- Have a nicotine test evaluated as negative prior to surgery and agree not to smoke for the duration of the study
- Be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
- Be eligible to enroll in one of the following three cohorts:
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- 1. Subject had radiation therapy (XRT) prior to direct-to-implant (DTI) reconstruction, but will not have XRT following reconstruction;
- 2. Subject did not have XRT prior to DTI reconstruction and will not have XRT following reconstruction;
- 3. Subject did not have XRT prior to DTI reconstruction, but will have XRT following reconstruction.
Who cannot join
- To be eligible for enrollment, the subject must not:
- Have collagen-vascular, connective tissue, or bleeding disorders
- Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- Have an autoimmune disease, an immune deficiency, or is on immune-suppression drugs for reasons other than current treatment for breast cancer
- Have a BMI that is ≥ 32
- Have a nicotine test evaluated as positive prior to surgery or unwilling to quit smoking for the duration of the study
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- Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
- Be pregnant, lactating, or expecting to be within the next 24 months
- Have concomitant unrelated condition of breast/chest wall/skin (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
- Require the use of any additional implant for soft tissue support of the contralateral non-study breast, except in bilateral breast reconstructions, where the use of SERI® Surgical Scaffold is allowed
- Have had a prior soft tissue support implant
- If enrolled into the Pre-Radiated cohort, have had recent radiation (< 1 year) to the breast/chest wall
- If enrolled into the Post-Radiated cohort, radiation to the breast/chest wall is planned more than 1 year from the time of SERI® Surgical Scaffold placement
- Have clinical evidence of severe radiation tissue damage (e.g. pigmentation, indentation, atrophy, no elasticity to skin of radiated breast) from previous XRT to the breast/chest wall
- Have large or multiple scars on the breast(s) that may interfere with blood supply to the mastectomy flaps
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, single center, postmarket clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.
- Conditions
- Breast Reconstruction
- Being tested
- Silk surgical mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk surgical meshDevice
A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
| Study group | Role | What they receive |
|---|---|---|
| Pre-radiated | Experimental | Not described Receives: Device: Silk surgical mesh |
| Not radiated | Experimental | Not described Receives: Device: Silk surgical mesh |
| Post-radiated | Experimental | Not described Receives: Device: Silk surgical mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Implant Loss
Implant Loss will be defined as situations in which the breast implant is removed and not immediately replaced.
Measured: 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sofregen Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914653
- Sponsor's protocol ID
- SURE-006
- Status last verified
- Oct 2017
- First submitted
- 31 Jul 2013
- Last updated
- 9 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction
- ClinicalTrials.gov ID
- NCT01914653
- Acronym / sponsor ID
- SURE-006
- Conditions
- Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sofregen Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Aug 2013 (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.
Prospective, single center, postmarket clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-radiated | Experimental | Device: Silk surgical mesh |
| Not radiated | Experimental | Device: Silk surgical mesh |
| Post-radiated | Experimental | Device: Silk surgical mesh |
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)
- Be female, ≥ 18 years of age
- If the subject is a female of childbearing potential, have a pregnancy test evaluated as negative prior to surgery, per the site's standard of care
- Have a nicotine test evaluated as negative prior to surgery and agree not to smoke for the duration of the study
- Be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
- Be eligible to enroll in one of the following three cohorts:
Key exclusion criteria (15 listed)
- Have collagen-vascular, connective tissue, or bleeding disorders
- Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- Have an autoimmune disease, an immune deficiency, or is on immune-suppression drugs for reasons other than current treatment for breast cancer
- Have a BMI that is ≥ 32
- Have a nicotine test evaluated as positive prior to surgery or unwilling to quit smoking for the duration of the study
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 |
|---|---|---|
| Silk surgical meshA CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair | Device | Not radiated, Post-radiated, Pre-radiated |
Primary outcome
Incidence of Implant Loss
Time frame: 24 months postoperatively
Implant Loss will be defined as situations in which the breast implant is removed and not immediately replaced.
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 9 Oct 2017.
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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.
Medical Director study director
Allergan Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silk surgical mesh in people with Breast Reconstruction, run by Sofregen Medical, Inc. at 1 site in Israel.
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 15 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 9 Oct 2017. 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 Israel. 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?
Incidence of Implant Loss (time frame: 24 months postoperatively). 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 9 Oct 2017.