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

NCT01885572 | Completed DMC

• 1 other identifier: pfm 12k001 TiLOOP Bra
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 8

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

Conditions

Breast Reconstruction After Mastectomy

Keywords

breast reconstruction; mastectomy; mesh; breast cancer

Outcome Measures

Primary Outcomes (1)

• PRO

  Measurement of the Patient Reported Outcome (PRO).

  12 months after breast reconstruction

Secondary Outcomes (4)

• PRO

  6 and 24 months after breast reconstruction

• Complication Rate

  after 6, 12 and 24 months

• Cosmetic Success

  6, 12 and 24 months after breast reconstruction

• PRO and Complication Rate

  48 months after breast reconstruction

Study Arms (1)

TiLOOP Bra

OTHER

Treatment with TiLOOP Bra

Device: TiLOOP Bra

Interventions

TiLOOP Bra DEVICE

Titaniferously coated polypropylene mesh

TiLOOP Bra

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Patients must be excluded if any of the following conditions exist or cannot be excluded:
• Pathological or physical condition precluding such as:
• Pregnancy or breast-feeding patients
• Known intolerance to the mesh-implants under investigation.
• 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
• 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.

Sponsors & Collaborators

• Pfm Medical Mepro Gmbh: lead
• pfm medical gmbh: collaborator

Study Sites (8)

Charite Campus Mitte and Benjamin Franklin

Berlin, 10117, Germany

Location

St. Gertrauden Krankenhaus

Berlin, 10713, Germany

Location

Vivantes Kliniken am Urban

Berlin, 10967, Germany

Location

Helios Kliniken

Berlin, 13125, Germany

Location

St. Elisabeth Krankenhaus

Cologne, 50935, Germany

Location

Agaplesion Markus Krankenhaus

Frankfurt am Main, 60431, Germany

Location

Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde

Lübeck, Germany

Location

Technische Universität

München, 81675, Germany

Location

Related Publications (2)

• 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.

  PMID: 32336622 RESULT

• 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.

  PMID: 30349788 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stefan Paepke, MD

  Technical University Munich, Ismaningerstrasse 22, 81675 Munich, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 25, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: June 1, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)