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Breast Reconstruction After MastectomyPRO-BRANCT01885572

National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra

A study testing TiLOOP Bra in people with Breast Reconstruction After Mastectomy, run by Pfm Medical Mepro Gmbh at 8 sites in Germany.

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

This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Reconstruction After Mastectomy
What is being tested?
TiLOOP Bra
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
267 participants
Where
8 sitesGermany
Study dates
Nov 2013to Jun 2021
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The TiLOOP®Bra is designed to assist oncologically indexed skin sparing mastectomy or subcutaneous mastectomy with preservation of the nipple-areola-complex during primary breast reconstruction, secondary breast reconstruction or corrective breast surgery. Patients shall be included if they meet all of the following criteria:
  • Clinical Criteria (reason):
  • women with indication of prophylactic operation or oncoplastic operation with support of a mesh implant
  • women with histologically confirmed breast cancer or precancerosis or genetic pre-existing conditions with increased risk of breast cancer or with a family history
  • the health of women must comply with ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • Study-related inclusion criteria - Legal reasons:
Show all 9Show fewer
  • Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
  • Patient information has been handed out and all written consents are at hand.
  • Patient is between 18 and 70 years old.

Who cannot join

  • Patients must be excluded if any of the following conditions exist or cannot be excluded:
  • Device-related exclusion criteria (contraindications):
  • Pathological or physical condition precluding such as:
  • Pregnancy or breast-feeding patients
  • Known intolerance to the mesh-implants under investigation.
  • Study-related exclusion criteria - Medical reasons:
Show all 16Show fewer
  • metastatic breast cancer
  • medicamentous regulated diabetes with blood sugar level >250
  • inadequate bone marrow function with neutrophil granulocytes <1500 and blood plates < 10000/µl
  • patient with known contraindication to mesh-implants or plastic-reconstructive breast operations
  • Study-related exclusion criteria - Legal reasons:
  • Lack of written patients informed consent.
  • Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
  • Patient is institutionalized by court or official order (MPG§20.3).
  • Participation in another operative clinical investigation.
  • It is thought that the study-related exclusion criteria will not significantly influence the sample of the population under investigation.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Germany8 sites

  • Charite Campus Mitte and Benjamin Franklin

    Berlin, 10117

  • St. Gertrauden Krankenhaus

    Berlin, 10713

  • Vivantes Kliniken am Urban

    Berlin, 10967

  • Helios Kliniken

    Berlin, 13125

  • St. Elisabeth Krankenhaus

    Cologne, 50935

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, 60431

  • Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde

    Lübeck

  • Technische Universität

    München, 81675

Other trials in Germany

About this study

Official title: National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)

This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation.

The objective of this clinical investigation is to establish the feasibility, efficacy and safety of the TiLOOP® Bra.

Being tested
TiLOOP Bra
Keywords
breast reconstruction, mastectomy, mesh, breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • TiLOOP BraDevice

    Titaniferously coated polypropylene mesh

Study groups in NCT01885572
Study groupRoleWhat they receive
TiLOOP BraOtherTreatment with TiLOOP Bra
Receives: Device: TiLOOP Bra

What is being measured

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

  1. PRO

    Measurement of the Patient Reported Outcome (PRO).

    Measured: 12 months after breast reconstruction

Secondary outcomes (4)

  1. PRO

    Measurement of the Patient Reported Outcome

    Measured: 6 and 24 months after breast reconstruction

  2. Complication Rate

    Complication rate of the first 60 patients in the 6 month follow-up and of all patients after 6, 12 and 24 months.

    Measured: after 6, 12 and 24 months

  3. Cosmetic Success

    Cosmetic success confirming the reinforcement will be assessed by the patient and an independent professional at a photo. The questions posed are part of the validated Breast Q questionnaire.

    Measured: 6, 12 and 24 months after breast reconstruction

  4. PRO and Complication Rate

    Measurement of the Patient Reported Outcome and complication rate of all patients

    Measured: 48 months after breast reconstruction

Timeline

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

  1. First posted25 Jun 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionAug 2017
  4. Study completionJun 2021

Resources

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
267 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01885572
Sponsor's protocol ID
pfm 12k001 TiLOOP Bra
Acronym
PRO-BRA
Status last verified
Sep 2021
First submitted
24 May 2013
Last updated
20 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thill M, Faridi A, Meire A, Gerber-Schafer C, Baumann K, Blohmer JU, Mau C, Tofall S, Nolte E, Strittmatter HJ, Ohlinger R, Paepke S. Patient reported outcome and cosmetic evaluation following implant-based breast-reconstruction with a titanized polypropylene mesh (TiLOOP(R) Bra): A prospective clinical study in 269 patients. Eur J Surg Oncol. 2020 Aug;46(8):1484-1490. doi: 10.1016/j.ejso.2020.04.009. Epub 2020 Apr 15.

    PubMed 32336622

  • Nolte E, Klein E, Paepke S. Pregnancy following Unilateral Immediate Breast Reconstruction with Titanized Polypropylene Mesh (TiLOOP(R) Bra) without Compromising the Result. Plast Reconstr Surg Glob Open. 2018 Sep 14;6(9):e1919. doi: 10.1097/GOX.0000000000001919. eCollection 2018 Sep.

    PubMed 30349788

  • Thill M, Klein E, Nolte E, Forster J, Ankel C, Gerber-Schafer C, Baumann K, Meire A, Mau C, Blohmer JU, Faridi A, Paepke S. Complication rate after implant-based breast-reconstruction with support of a synthetic non-resorbable titanized polypropylene mesh (TiLOOP(R) Bra): Analysis of the 2-year follow up from the prospective multicentre PRO-BRA trial. JPRAS Open. 2026 Jun 26;51:269-282. doi: 10.1016/j.jpra.2026.05.057. eCollection 2026 Sep.

    PubMed 42519399

Questions about this trial

What is this clinical trial studying?

A study testing TiLOOP Bra in people with Breast Reconstruction After Mastectomy, run by Pfm Medical Mepro Gmbh at 8 sites in Germany.

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 9 inclusion and 16 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 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany. 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?

PRO (time frame: 12 months after breast reconstruction). 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 NCT01885572, which also lists 3 linked publications.

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 20 Sep 2021.

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