Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket) (PRO-Pocket)

November 15, 2023 updated by: pfm medical ag

"PRO-Pocket" - International Prospective Multicenter Post Market Clinical Follow Up to "Patient Reported Outcome" in Primary or Secondary Breast Reconstruction After Mastectomy Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)

"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra Pocket)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This international, multicentre, non-randomised, observational clinical device investigation will be performed to obtain post market information on TiLOOP® Bra Pocket surgical meshes for a period of up to two years. In particular, on patient reported satisfaction (BreastQTM), cosmetic outcome and the rate of complications.

The objective of the clinical Investigation is to establish the efficacy and safety of the TiLOOP® Bra Pocket.

The Investigation will be performed in ten clinical centres in Germany and Austria.

Study Type

Observational

Enrollment (Actual)

313

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien
  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum am Urban
      • Berlin, Germany, 14050
        • DRK Kliniken Westend
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn
      • Essen, Germany, 45136
        • Kliniken Essen Mitte; Evang. Huyssens-Stiftung
      • Frankfurt, Germany, 60431
        • Agaplesion Markus Krankenhaus
      • Greifswald, Germany, 17475
        • Universitätsmedizin Greifswald
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Munich, Germany, 80637
        • Rotkreuzklinikum Munchen
      • Munich, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universitat Munchen
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm
      • Weinheim, Germany
        • GRN Klinik Weinheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women with indicated implant based breast reconstruction after mastectomy.

Description

Inclusion Criteria:

Age [≥ 18]

Indications of breast reconstruction: histologically confirmed breast cancer, precancerous lesions (DCIS, LCIS), mutation carrier with increased breast cancer risk, strong family history (lifetime risk > 15%)

The patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1)

Patient information has been provided and all written consents of the patient are available

Exclusion Criteria:

Metastatic breast cancer

Patient with known contraindications against mesh-assisted or plastic-reconstructive breast surgery according to the instruction for use

Patient is kept in an institution under judicial or official orders (MPG §20.3)

Participate in another operative clinical trial, if it relates to the area of reconstructive breast surgery and/or influences the primary endpoint of the clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TiLOOP Bra Pocket
Medical Device
Device: TiLOOP® Bra Pocket
Primary or secondary breast reconstruction following mastectomy with titanised polypropylene mesh TiLOOP® Bra Pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life - Patient reported outcome
Time Frame: 12 months after study treatment
The primary endpoint is defined as the change of the four BreastQ domain scores before study treatment compared to twelve months after study treatment. The BreastQ questionnaire yields a domain score in the range from zero to 100. Wheras a score of 100 is the best score. The study hypothesis is that the patient's QoL after the study intervention treatment is not worse than the QoL prior to the intervention study treatment . The following four domains are relavant: Satisfaction with breasts, Psychosocial well-being, Physical well-being:chest and Sexual well-being.
12 months after study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life - Patient reported outcome
Time Frame: 6 and 24 months after study treatment
The change of the four BreastQ domain scores before study treatment compared to six months and 24 months after study treamtment.
6 and 24 months after study treatment
Complication rate
Time Frame: 6, 12 and 24 months after study treatment
The number and rate of occurrence of adverse events is reported as a secondary endpoint along with a tabulation of the types of adverse events (6, 12 and 24 months after study treatment).
6, 12 and 24 months after study treatment
Cosmetic outcome
Time Frame: 6, 12 and 24 months after study treatment
The cosmetic outcome is assessed based on photographs 6, 12 and 24 months after study treatment by descriptive statistics (an independent expert, the physician in charge and the patient assess the cosmetic outcome).
6, 12 and 24 months after study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

pfm medical ag

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2019

Primary Completion (Actual)

June 22, 2022

Study Completion (Actual)

November 15, 2023

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P050001 TiLOOP® Bra Pocket

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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