Breast ReconstructionNCT01256502

The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery

A study testing SERI® Surgical Scaffold in people with Breast Reconstruction, run by Sofregen Medical, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for 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?: SERI® Surgical Scaffold
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteUnited States
Study dates: Oct 2010to Apr 2014
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

To be eligible for enrollment, the subject must:
Be female, greater or equal to 18 years of age
Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant
Have previously had or 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

The subject must not:
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 collagen-vascular, connective disease, or bleeding disorders
Have a Body Mass Index (BMI) that is greater than or equal to 35
Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability

Show all 15Show fewer

Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer
Have smoked within the last 12 months
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
Have an abscess or infection at the time of surgery
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

1 site in 1 country.

United States1 site

Study site
Los Angeles, California

Other trials in United States

About this study

The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.

Conditions: Breast Reconstruction
Being tested: SERI® Surgical Scaffold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SERI® Surgical ScaffoldDevice
Breast reconstruction surgery

Study groups in NCT01256502
Study group	Role	What they receive
Implanted Participants	Other	Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold. Receives: Device: SERI® Surgical Scaffold

What is being measured

The primary outcome is the main question the study is designed to answer.

Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months
The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Measured: 6 months

Secondary outcomes (2)

Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery
Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported.
Measured: Immediately following Stage I surgery
Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points
Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.
Measured: Stage 2 Surgery, Months 12, 18 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Apr 2014

First posted8 Dec 2010 (estimated)
Study startOct 2010
Primary completionOct 2012
Study completionApr 2014

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 (1)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01256502
Sponsor's protocol ID: SURE-001
Status last verified: Oct 2017
First submitted: 7 Dec 2010
Last updated: 6 Nov 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Fine NA, Lehfeldt M, Gross JE, Downey S, Kind GM, Duda G, Kulber D, Horan R, Ippolito J, Jewell M. SERI surgical scaffold, prospective clinical trial of a silk-derived biological scaffold in two-stage breast reconstruction: 1-year data. Plast Reconstr Surg. 2015 Feb;135(2):339-351. doi: 10.1097/PRS.0000000000000987.
PubMed 25502862

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Reconstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
ClinicalTrials.gov ID: NCT01256502
Acronym / sponsor ID: SURE-001
Conditions: Breast Reconstruction
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Sofregen Medical, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Oct 2012 (actual)
Study completion: Apr 2014 (actual)
First posted: 8 Dec 2010 (estimated)
Results: Posted 16 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Implanted Participants	Other	Device: SERI® 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 (5 listed)

Be female, greater or equal to 18 years of age
Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant
Have previously had or 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 (15 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 collagen-vascular, connective disease, or bleeding disorders
Have a Body Mass Index (BMI) that is greater than or equal to 35
Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability

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 ScaffoldBreast reconstruction surgery	Device	Implanted Participants

Primary outcome

Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months
Time frame: 6 months
The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.

2 secondary outcomes

Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery
Time frame: Immediately following Stage I surgery
Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points
Time frame: Stage 2 Surgery, Months 12, 18 and 24

Results and safety

Results posted to the registry on 16 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implanted Participants	139	129

Primary outcome: Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months

Time frame: 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Implanted Participants n = 134
Value	9.4 (0.84)

Population analysed: Of the 139 participants, 214 breasts, implanted with SERI® during Stage I breast reconstruction, 4 discontinued the study and 1 missed the 6-month visit, leaving 134 subjects, 205 breasts in the primary analysis population.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 months following SERI implantation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implanted Participants	25 of 139 (18%)	107 of 139 (77%)	Not reported

Limitations and caveats (from the sponsor): None to report.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25502862Fine NA, Lehfeldt M, Gross JE, Downey S, Kind GM, Duda G, Kulber D, Horan R, Ippolito J, Jewell M. SERI surgical scaffold, prospective clinical trial of a silk-derived biological scaffold in two-stage breast reconstruction: 1-year data. Plast Reconstr Surg. 2015 Feb;135(2):339-351. doi: 10.1097/PRS.0000000000000987.

Related trials for Breast Reconstruction

Recruiting
ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
Breast Cancer, Cancer of the Breast
RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Breast Augmentation, Mammaplasty
Active, not recruiting
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Breast Reconstruction, Revision Breast Reconstruction
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer

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 Monitor 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 SERI® Surgical Scaffold in people with Breast Reconstruction, run by Sofregen Medical, Inc. 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 5 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 6 Nov 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 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 16 May 2014). 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 Following Use of SERI® Surgical Scaffold at 6 Months (time frame: 6 months). 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 NCT01256502, 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 6 Nov 2017.