Breast CancerNCT01959867
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
A study testing SurgiMend® PRS in people with Breast Cancer, run by Integra LifeSciences Corporation.
Trial summary
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SurgiMend® PRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2017
- 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
- Patient is at least 18 years of age
- Patient is female
- Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS
- Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy \& reconstruction)
- Patient utilized a textured expander only
- Patient utilized a smooth gel permanent implant only
- Patient has agreed and is able to comply with the study follow-up requirements
- Patient or guardian has provided consent for participation
Who cannot join
- Patient is undergoing single-stage breast reconstruction
- Patient is undergoing a delayed reconstruction
- Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant.
- Patient is undergoing planned reconstruction using autologous tissue
- Patient has a known hypersensitivity to collagen or bovine derived materials
- Patient is currently pregnant, nursing, or planning a pregnancy during the course of the study
- Patient who has had pre-mastectomy XRT bilaterally for breast cancer (either at the same time or separated in time)
About this study
Official title: Clinical Study Comparing Two-Stage Breast Reconstruction Following Mastectomy With and Without the Use of SurgiMend® PRS Fetal Bovine Collagen Matrix in Patients With Pre-Mastectomy Radiation Therapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Conditions
- Breast Cancer
- Being tested
- SurgiMend® PRS, No Intervention
- Keywords
- mastectomy, breast reconstruction, bovine, ADM, breast cancer, breast implants, breast expanders, radiation therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgiMend® PRSDevice
Also called ADM, acellular dermal matrix
Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).
No InterventionOther
Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).
| Study group | Role | What they receive |
|---|---|---|
| SurgiMend® PRS (ADM) | Experimental | Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion). Receives: Device: SurgiMend® PRS |
| No Intervention | Other | Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion). Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsular Contracture Rate
Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange
Measured: 12 months Post-Exchange
Breast Q
No decrease in overall patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, all questions a-p.
Increase in patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, questions related to capsular contracture.
Measured: 12 months Post-Exchange
Secondary outcomes (5)
No. Capsule Procedures
Number of capsule procedures performed
Measured: 12 months Post-Exchange
Cosmetic Assessment
Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs)
Measured: 12 months Post-Exchange
Time to Completion
Time to Completion (expand-to-implant exchange)
Measured: 12 months Post-Exchange
Total number of OR procedures
Procedural Attributes: Total number of OR procedures
Measured: 12 month follow-up visit
Total number of visits
Procedural Attributes: Total number of ("in office" and OR procedures)
Measured: 12 month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startJan 2017
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959867
- Sponsor's protocol ID
- TEI-BR-001
- Status last verified
- Jan 2017
- First submitted
- 27 Sep 2013
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Comparing Two-Stage Breast Reconstruction Following Mastectomy With and Without the Use of SurgiMend® PRS Fetal Bovine Collagen Matrix in Patients With Pre-Mastectomy Radiation Therapy
- ClinicalTrials.gov ID
- NCT01959867
- Acronym / sponsor ID
- TEI-BR-001
- Conditions
- Breast Cancer
- Keywords
- mastectomy, breast reconstruction, bovine, ADM, breast cancer, breast implants, breast expanders, radiation therapy
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Oct 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.
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SurgiMend® PRS (ADM) | Experimental | Device: SurgiMend® PRSSubjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion). |
| No Intervention | Other | Other: No InterventionSubjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is at least 18 years of age
- Patient is female
- Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS
- Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy \& reconstruction)
- Patient utilized a textured expander only
Key exclusion criteria (7 listed)
- Patient is undergoing single-stage breast reconstruction
- Patient is undergoing a delayed reconstruction
- Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant.
- Patient is undergoing planned reconstruction using autologous tissue
- Patient has a known hypersensitivity to collagen or bovine derived materials
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 |
|---|---|---|
| SurgiMend® PRSAlso: ADM, acellular dermal matrixSubjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion). | Device | SurgiMend® PRS (ADM) |
| No InterventionSubjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion). | Other | No Intervention |
Primary outcome
Capsular Contracture Rate
Time frame: 12 months Post-Exchange
Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange
Breast Q
Time frame: 12 months Post-Exchange
No decrease in overall patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, all questions a-p. Increase in patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, questions related to capsular contracture.
5 secondary outcomes
No. Capsule Procedures
Time frame: 12 months Post-Exchange
Cosmetic Assessment
Time frame: 12 months Post-Exchange
Time to Completion
Time frame: 12 months Post-Exchange
Total number of OR procedures
Time frame: 12 month follow-up visit
Total number of visits
Time frame: 12 month follow up visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SurgiMend® PRS in people with Breast Cancer, run by Integra LifeSciences Corporation.
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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Capsular Contracture Rate (time frame: 12 months Post-Exchange). The study lists 2 primary outcomes in all. 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 10 Jan 2017.