Breast CancerNCT01823107
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
A study testing Meso BioMatrix Device in people with Breast Cancer, run by Kensey Nash Corporation at 6 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast reconstruction. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Meso BioMatrix Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2012to 29 Jun 2017
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-smoker
- Undergoing unilateral or bilateral, two-stage, tissue expander-assisted breast reconstruction
- Life expectancy greater than 18 months
- Agreement to return for the trial required follow-up visits
Who cannot join
- Body mass index ≥ 35
- Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction mammoplasty
- History of chronic corticosteroid use
- Type I Diabetes
- History of radiation therapy to the chest
- Pre-operative treatment with induction chemotherapy for breast cancer
- Pregnancy
- Participating in another investigational drug or device trial that has not completed the follow-up period
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cancer Center of America at Eastern Regional Medical Center / Dr. Glat Plastic & Reconstructive Surgery
Bala-Cynwyd, Pennsylvania, 19004
Henry Ford Health System
Detroit, Michigan, 48202
Long Island Plasic Surgical Group, PC
Garden City, New York, 11530
Long Island Plastic Surgical Group, PC
Garden City, New York, 11530
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Utah (Huntsman Cancer Hospital)
Salt Lake City, Utah, 84112
About this study
Official title: Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial
The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast reconstruction.
Read the detailed description
Following mastectomy, women may elect to have breast reconstruction with autologous tissue or breast implants. Two-stage, tissue expander assisted breast reconstruction is one of the common surgical methods that could be selected to reconstruct the breast. This method either begins immediately after mastectomy (known as immediate breast reconstruction) or at some time afterward (known as delayed breast reconstruction). Historically, surgeons placed a tissue expander followed by the breast implant either completely or partially under the pectoralis muscle. However, this method of breast reconstruction has been associated with less favorable aesthetic outcomes.
Recently, surgeons started adding a surgical mesh derived from human cadaver skin during breast reconstruction procedures. In summary, during the first stage of the breast reconstruction, the plastic surgeon releases the pectoralis muscle from the chest wall. The surgeon then attaches the surgical mesh to the pectoralis muscle and to the chest wall just below the breast. This is done to create a pocket for the tissue expander. The tissue expander is implanted in the pocket and partially inflated. The tissue expander is gradually filled with saline over several weeks or months. Once the desired breast volume has been achieved, the second stage of the reconstruction takes place. In the second stage, the tissue expander is removed and replaced with a permanent saline or silicone gel breast implant.
Use of the human cadaver skin surgical mesh during breast reconstruction has been associated with less pain, fewer tissue expansion visits and improved aesthetic outcomes. However, the human cadaver skin surgical mesh adds significant cost to the procedure and some surgeons have reported an increased rate of post-operative complications.
Over the last 10 years, a number of surgical mesh devices have been cleared by the U.S. Food \& Drug Administration (FDA) for the reinforcement and repair weak soft tissue or became available as tissue grafts from human donors. Some surgeons have published their experience with a number of these surgical mesh devices for breast reconstruction. However, at present, no surgical mesh device is approved or cleared by the FDA for use in breast reconstruction.
The Meso BioMatrix device was recently cleared by the FDA for reinforcement and repair of weak soft tissue. It is a surgical mesh device that is made from pig peritoneum, the tissue that lines the abdominal cavity. The tissue is thoroughly cleaned and sterilized before use. When implanted, the Meso BioMatrix device provides structural and mechanical support to weak soft tissue during the healing process.
This clinical trial is a feasibility trial. A feasibility trial is a clinical trial in which a device is being studied in a small group of people for a new use. Since the Meso BioMatrix device is not cleared specifically for use in breast reconstruction, it is considered investigational and must be studied in a controlled, step-wise series of clinical trials. Therefore, the results of this trial, if successful, may be used to design a larger clinical trial in the future.
- Conditions
- Breast Cancer
- Being tested
- Meso BioMatrix Device
- Keywords
- Meso BioMatrix, Breast, Breast Cancer, Mastectomy, Biologic Mesh, Breast Reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meso BioMatrix DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Meso BioMatrix Device | Experimental | All subjects will have the Meso BioMatrix device implanted along with a tissue expander during the first stage of breast reconstruction. During the second stage of breast reconstruction, the tissue expander is replaced with a breast implant. Receives: Device: Meso BioMatrix Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Breast Related Adverse Events
Investigators evaluated each subject and each reconstructed breast for the occurrence of an adverse event from the first stage of reconstruction through the final follow-up visit. A breast related adverse event was defined as any untoward medical occurrence related to a reconstructed breast.
Measured: 18 months
Secondary outcomes (2)
Measurement of Aesthetic Satisfaction With the Use of the Breast-Q Survey
Subjects completed the reconstructive module of the BREAST-Q, a standardized instrument measuring patient satisfaction and health-related quality of life on a scale of 1 to 100, with higher scores indicating higher satisfaction. Completed Breast-Q questionnaires were scored according to the author's instructions. Aesthetic satisfaction was measured using the Breast-Q Satisfaction with Breasts subscale score.
Measured: 18 months (12 months after second stage reconstruction)
Rate of Reconstruction Failure
Reconstruction failure was defined as a serious adverse event in a reconstructed breast resulting in unplanned removal of the prosthesis and/or Meso BioMatrix Acellular Peritoneum Matrix.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2017
- Study completion29 Jun 2017
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kensey Nash Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Forde Hansell, Study director, DSM Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823107
- Sponsor's protocol ID
- MESO-001
- Status last verified
- Aug 2018
- First submitted
- 26 Mar 2013
- Last updated
- 10 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Simpson AM, Higdon KK, Kilgo MS, Tepper DG, Alizadeh K, Glat PM, Agarwal JP. Porcine Acellular Peritoneal Matrix in Immediate Breast Reconstruction: A Multicenter, Prospective, Single-Arm Trial. Plast Reconstr Surg. 2019 Jan;143(1):10e-21e. doi: 10.1097/PRS.0000000000005095.
PubMed 30589773
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial
- ClinicalTrials.gov ID
- NCT01823107
- Acronym / sponsor ID
- MESO-001
- Conditions
- Breast Cancer
- Keywords
- Meso BioMatrix, Breast, Breast Cancer, Mastectomy, Biologic Mesh, Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kensey Nash CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 10 Sep 2019
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 evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast reconstruction.
Detailed description
Following mastectomy, women may elect to have breast reconstruction with autologous tissue or breast implants. Two-stage, tissue expander assisted breast reconstruction is one of the common surgical methods that could be selected to reconstruct the breast. This method either begins immediately after mastectomy (known as immediate breast reconstruction) or at some time afterward (known as delayed breast reconstruction). Historically, surgeons placed a tissue expander followed by the breast implant either completely or partially under the pectoralis muscle. However, this method of breast reconstruction has been associated with less favorable aesthetic outcomes.
Recently, surgeons started adding a surgical mesh derived from human cadaver skin during breast reconstruction procedures. In summary, during the first stage of the breast reconstruction, the plastic surgeon releases the pectoralis muscle from the chest wall. The surgeon then attaches the surgical mesh to the pectoralis muscle and to the chest wall just below the breast. This is done to create a pocket for the tissue expander. The tissue expander is implanted in the pocket and partially inflated. The tissue expander is gradually filled with saline over several weeks or months. Once the desired breast volume has been achieved, the second stage of the reconstruction takes place. In the second stage, the tissue expander is removed and replaced with a permanent saline or silicone gel breast implant.
Use of the human cadaver skin surgical mesh during breast reconstruction has been associated with less pain, fewer tissue expansion visits and improved aesthetic outcomes. However, the human cadaver skin surgical mesh adds significant cost to the procedure and some surgeons have reported an increased rate of post-operative complications.
Over the last 10 years, a number of surgical mesh devices have been cleared by the U.S. Food \& Drug Administration (FDA) for the reinforcement and repair weak soft tissue or became available as tissue grafts from human donors. Some surgeons have published their experience with a number of these surgical mesh devices for breast reconstruction. However, at present, no surgical mesh device is approved or cleared by the FDA for use in breast reconstruction.
The Meso BioMatrix device was recently cleared by the FDA for reinforcement and repair of weak soft tissue. It is a surgical mesh device that is made from pig peritoneum, the tissue that lines the abdominal cavity. The tissue is thoroughly cleaned and sterilized before use. When implanted, the Meso BioMatrix device provides structural and mechanical support to weak soft tissue during the healing process.
This clinical trial is a feasibility trial. A feasibility trial is a clinical trial in which a device is being studied in a small group of people for a new use. Since the Meso BioMatrix device is not cleared specifically for use in breast reconstruction, it is considered investigational and must be studied in a controlled, step-wise series of clinical trials. Therefore, the results of this trial, if successful, may be used to design a larger clinical trial in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meso BioMatrix Device | Experimental | Device: Meso BioMatrix DeviceAll subjects will have the Meso BioMatrix device implanted along with a tissue expander during the first stage of breast reconstruction. During the second stage of breast reconstruction, the tissue expander is replaced with a breast implant. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-smoker
- Undergoing unilateral or bilateral, two-stage, tissue expander-assisted breast reconstruction
- Life expectancy greater than 18 months
- Agreement to return for the trial required follow-up visits
Key exclusion criteria (8 listed)
- Body mass index ≥ 35
- Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction mammoplasty
- History of chronic corticosteroid use
- Type I Diabetes
- History of radiation therapy to the chest
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 |
|---|---|---|
| Meso BioMatrix Device | Device | Meso BioMatrix Device |
Primary outcome
Rate of Breast Related Adverse Events
Time frame: 18 months
Investigators evaluated each subject and each reconstructed breast for the occurrence of an adverse event from the first stage of reconstruction through the final follow-up visit. A breast related adverse event was defined as any untoward medical occurrence related to a reconstructed breast.
2 secondary outcomes
Measurement of Aesthetic Satisfaction With the Use of the Breast-Q Survey
Time frame: 18 months (12 months after second stage reconstruction)
Rate of Reconstruction Failure
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30589773Simpson AM, Higdon KK, Kilgo MS, Tepper DG, Alizadeh K, Glat PM, Agarwal JP. Porcine Acellular Peritoneal Matrix in Immediate Breast Reconstruction: A Multicenter, Prospective, Single-Arm Trial. Plast Reconstr Surg. 2019 Jan;143(1):10e-21e. doi: 10.1097/PRS.0000000000005095.
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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.
Forde Hansell study director
DSM Biomedical
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meso BioMatrix Device in people with Breast Cancer, run by Kensey Nash Corporation at 6 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 4 inclusion and 8 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 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 10 Sep 2019). 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?
Rate of Breast Related Adverse Events (time frame: 18 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 NCT01823107, 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 10 Sep 2019.