MammoplastyAPPeaRNCT03744013
A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis
A study testing Fortiva® 1mm in people with Mammoplasty, run by RTI Surgical at 6 sites in 2 countries.
Trial summary
This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Mammoplasty
- What is being tested?
- Fortiva® 1mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 7 May 2019to 9 Jan 2024
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female 18 years or older
- A candidate for immediate breast reconstruction during post-skin sparing or nipple-sparing mastectomy (unilateral or bilateral)
- Estimated life expectancy > 2 years
- Able and willing to return for all scheduled and required study visits
- Able to provide written informed consent for study participation
- Able to read, understand and complete study questionnaires
Who cannot join
- Any of the conditions listed in the approved labeling as contraindicated
- Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
- Any patient that per the physician's judgement is not a good candidate for this study
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites
Agaplesion Markus Krankenhaus
Frankfurt am Main, 60431
Frankfurt University Hospital
Frankfurt am Main, 60590
University Hospital Technical University, Munich
München, 81664
University Hospital, Ulm
Ulm, 89081
United Kingdom2 sites
Guy's Hospital
London, SE1 9RT
Nightingale Breast Unit, Manchester University NHS Foundation Trust (MFT), Wythenshawe Hospital
Manchester, M23 9LT
About this study
Official title: A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction
This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe.
- Conditions
- Mammoplasty
- Being tested
- Fortiva® 1mm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortiva® 1mmDevice
Post mastectomy immediate reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Perforated | Active comparator | Fortiva® 1mm perforated ADM Receives: Device: Fortiva® 1mm |
| Non-perforated | Active comparator | Fortiva® 1mm non-perforated ADM Receives: Device: Fortiva® 1mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Fortiva® tissue matrix
Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.
Measured: 24 months
Performance of Fortiva® tissue matrix
- Analysis of the subject's overall satisfaction with the breast reconstruction procedure will be assessed by obtaining subject's perception of the outcomes using the Breast-QTM - Reconstruction survey.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start7 May 2019
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammoplastyStudies 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
- Single group
- Model description
- post market prospective, multi-center study
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744013
- Sponsor's protocol ID
- CL1104
- Acronym
- APPeaR
- Status last verified
- May 2024
- First submitted
- 14 Nov 2018
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03744013
- Acronym / sponsor ID
- APPeaR / CL1104
- Conditions
- Mammoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Study start
- 7 May 2019 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 16 Nov 2018 (actual)
- 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 post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- post market prospective, multi-center study
| Arm | Type | Receives |
|---|---|---|
| Perforated | Active comparator | Device: Fortiva® 1mmFortiva® 1mm perforated ADM |
| Non-perforated | Active comparator | Device: Fortiva® 1mmFortiva® 1mm non-perforated ADM |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female 18 years or older
- A candidate for immediate breast reconstruction during post-skin sparing or nipple-sparing mastectomy (unilateral or bilateral)
- Estimated life expectancy > 2 years
- Able and willing to return for all scheduled and required study visits
- Able to provide written informed consent for study participation
Key exclusion criteria (3 listed)
- Any of the conditions listed in the approved labeling as contraindicated
- Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
- Any patient that per the physician's judgement is not a good candidate for this 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 |
|---|---|---|
| Fortiva® 1mmPost mastectomy immediate reconstruction | Device | Non-perforated, Perforated |
Primary outcome
Safety of Fortiva® tissue matrix
Time frame: 24 months
Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.
Performance of Fortiva® tissue matrix
Time frame: 24 months
• Analysis of the subject's overall satisfaction with the breast reconstruction procedure will be assessed by obtaining subject's perception of the outcomes using the Breast-QTM - Reconstruction survey.
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 2 May 2024.
- 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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortiva® 1mm in people with Mammoplasty, run by RTI Surgical at 6 sites in 2 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 6 inclusion and 3 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 2 May 2024. 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 Germany, 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?
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?
Safety of Fortiva® tissue matrix (time frame: 24 months). 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 2 May 2024.