Soft Tissue Support and RepairNCT01389232
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
A study testing SeriScaffold® Surgical Scaffold in people with Soft Tissue Support and Repair, run by Sofregen Medical, Inc. at 5 sites in 4 countries.
Trial summary
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Soft Tissue Support and Repair
- What is being tested?
- SeriScaffold® Surgical Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Jun 2011to Feb 2015
- 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
- Be female, greater or equal to 18 years of age
- Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant
- Be willing to undergo mastectomy with healthy, well vascularized skin flaps anticipated by the surgeon
- Be in good health other than breast pathology and be suited to general anesthesia and planned treatments
Who cannot join
- Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study
- Have a known allergy to silk
- Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation
- Have had a prior soft tissue support device implanted in the breast
- Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
- Conditions
- Soft Tissue Support and Repair
- Being tested
- SeriScaffold® Surgical Scaffold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeriScaffold® Surgical ScaffoldDevice
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 |
|---|---|---|
| SeriScaffold® Surgical Scaffold | Experimental | Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. Receives: Device: SeriScaffold® Surgical Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Measured: Month 6
Secondary outcomes (4)
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Measured: Month 3, Month 12, Month 18, Month 24
Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale
Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use.
Measured: Immediately Following Stage 1 Surgery
Breast Anatomy Measurements
Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold.
Measured: Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24
Subject Satisfaction With Breasts on a 5-Point Scale
Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2013
- Study completionFeb 2015
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 Soft Tissue Support and RepairStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sofregen Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389232
- Sponsor's protocol ID
- SURE-002
- Status last verified
- May 2021
- First submitted
- 6 Jul 2011
- Last updated
- 21 Jun 2021
- 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 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
- ClinicalTrials.gov ID
- NCT01389232
- Acronym / sponsor ID
- SURE-002
- Conditions
- Soft Tissue Support and Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sofregen Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Posted 21 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SeriScaffold® Surgical Scaffold | Experimental | Device: SeriScaffold® Surgical ScaffoldParticipants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be female, greater or equal to 18 years of age
- Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant
- Be willing to undergo mastectomy with healthy, well vascularized skin flaps anticipated by the surgeon
- Be in good health other than breast pathology and be suited to general anesthesia and planned treatments
Key exclusion criteria (6 listed)
- Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study
- Have a known allergy to silk
- Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation
- Have had a prior soft tissue support device implanted in the breast
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 |
|---|---|---|
| SeriScaffold® Surgical ScaffoldA 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 | SeriScaffold® Surgical Scaffold |
Primary outcome
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
Time frame: Month 6
Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
4 secondary outcomes
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale
Time frame: Month 3, Month 12, Month 18, Month 24
Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale
Time frame: Immediately Following Stage 1 Surgery
Breast Anatomy Measurements
Time frame: Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24
Subject Satisfaction With Breasts on a 5-Point Scale
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SeriScaffold® Surgical Scaffold in people with Soft Tissue Support and Repair, run by Sofregen Medical, Inc. at 5 sites in 4 countries.
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 4 inclusion and 6 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 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Italy, Spain, United Kingdom. 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 21 Jun 2021). 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?
Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale (time frame: Month 6). 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 21 Jun 2021; AzTrials last refreshed its copy on 30 Oct 2026.