Breast CancerPhase 4NCT02562170
Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
A Phase 4 study testing TiLoop Bra and Protexa in people with Breast Cancer and Hereditary Breast and Ovarian Cancer Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Hereditary Breast and Ovarian Cancer Syndrome
- What is being tested?
- TiLoop Bra and Protexa
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2013to May 2015
- Phase
- Phase 4
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patients with indication for skin or nipple sparing mastectomy
- BRCA1/2 mutation carriers with indication for skin or nipple sparing mastectomy
Who cannot join
- prior local radiotherapy
- inflammatory breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.
- Being tested
- TiLoop Bra, Protexa
- Keywords
- breast, reconstruction, mesh, acellular dermal matrix
- Medical subject headings
- Breast Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiLoop BraDevice
ProtexaDevice
| Study group | Role | What they receive |
|---|---|---|
| TiLoop Bra | Active comparator | immediate breast reconstruction with an implant and TiLoop Bra Receives: Device: TiLoop Bra |
| Protexa | Active comparator | immediate breast reconstruction with an implant and Protexa Receives: Device: Protexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
Measured: up to two weeks after surgery
change of baseline patient quality of life after 3 and 6 months
questionnaire
Measured: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
change of baseline cosmetic outcome after 3 and 6 months
four point Harris Scale (1=poor, 4=excellent)
Measured: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months
The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound
Measured: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
complications
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
Measured: 3 months after surgery
complications
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startJul 2013
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daphne Gschwantler-Kaulich, Medical University of Vienna
- Investigators
- Daphne Gschwantler-Kaulich, Ass.Prof.Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562170
- Sponsor's protocol ID
- 1401/2013
- Status last verified
- Sep 2015
- First submitted
- 18 Sep 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gschwantler-Kaulich D, Schrenk P, Bjelic-Radisic V, Unterrieder K, Leser C, Fink-Retter A, Salama M, Singer C. Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial. Eur J Surg Oncol. 2016 May;42(5):665-71. doi: 10.1016/j.ejso.2016.02.007. Epub 2016 Feb 23.
PubMed 26947961
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
- ClinicalTrials.gov ID
- NCT02562170
- Acronym / sponsor ID
- 1401/2013
- Keywords
- breast, reconstruction, mesh, acellular dermal matrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Sep 2015 (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.
Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TiLoop Bra | Active comparator | Device: TiLoop Braimmediate breast reconstruction with an implant and TiLoop Bra |
| Protexa | Active comparator | Device: Protexaimmediate breast reconstruction with an implant and Protexa |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- breast cancer patients with indication for skin or nipple sparing mastectomy
- BRCA1/2 mutation carriers with indication for skin or nipple sparing mastectomy
Key exclusion criteria (2 listed)
- prior local radiotherapy
- inflammatory breast cancer
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 |
|---|---|---|
| TiLoop Bra | Device | TiLoop Bra |
| Protexa | Device | Protexa |
Primary outcome
complications
Time frame: up to two weeks after surgery
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
change of baseline patient quality of life after 3 and 6 months
Time frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
questionnaire
change of baseline cosmetic outcome after 3 and 6 months
Time frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
four point Harris Scale (1=poor, 4=excellent)
change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months
Time frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound
complications
Time frame: 3 months after surgery
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
complications
Time frame: 6 months after surgery
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
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 29 Sep 2015.
- Derived from this study: PubMed 26947961Gschwantler-Kaulich D, Schrenk P, Bjelic-Radisic V, Unterrieder K, Leser C, Fink-Retter A, Salama M, Singer C. Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial. Eur J Surg Oncol. 2016 May;42(5):665-71. doi: 10.1016/j.ejso.2016.02.007. Epub 2016 Feb 23.
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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.
Daphne Gschwantler-Kaulich, Ass.Prof.Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TiLoop Bra and Protexa in people with Breast Cancer and Hereditary Breast and Ovarian Cancer Syndrome, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 2 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 29 Sep 2015. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
complications (time frame: up to two weeks after surgery). The study lists 6 primary outcomes in all. 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 NCT02562170, 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 29 Sep 2015.