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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03868514
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
pfm medical ag

Brief Summary:
"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)

Condition or disease Intervention/treatment
Breast Reconstruction After Mastectomy Device: TiLOOP® Bra Pocket

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "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)
Actual Study Start Date : July 4, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with indicated implant based breast reconstruction after mastectomy.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868514


Contacts
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Contact: Katja Klein 0049 22369641 ext 250 katja.klein@pfmmedical.com

Locations
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Austria
Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien Recruiting
Vienna, Austria, 1090
Contact: Daphne Gschwantler-Kaulich, Assoc. Prof.         
Principal Investigator: Daphne Geschwantler-Kaulich, Assoc. Prof.         
Germany
Vivantes Klinikum Am Urban Recruiting
Berlin, Germany, 10967
Contact: Claudia Gerber-Schäfer, Dr.         
Principal Investigator: Claudia Gerber-Schäfer, Dr.         
DRK Kliniken Westend Recruiting
Berlin, Germany, 14050
Contact: Christine Ankel, Dr.         
Principal Investigator: Christine Ankel, Dr.         
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53127
Contact: Andree Faridi, Prof. Dr.         
Principal Investigator: Andree Faridi, Prof. Dr.         
Kliniken Essen Mitte; Evang. Huyssens-Stiftung Recruiting
Essen, Germany, 45136
Contact: Sherko Kümmel, Prof. Dr.         
Principal Investigator: Sherko Kümmel, Prof. Dr.         
Agaplesion Markus Krankenhaus Recruiting
Frankfurt, Germany, 60431
Contact: Marc Thill, Prof. Dr.         
Principal Investigator: Marc Thill, Dr.         
Universitätsmedizin Greifswald Completed
Greifswald, Germany, 17475
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Jörg Heil, Prof. Dr.         
Principal Investigator: Jörg Heil, Prof. Dr.         
Rotkreuzklinikum München Completed
Munich, Germany, 80637
Klinikum rechts der Isar der Technischen Universität München Recruiting
Munich, Germany, 81675
Contact: Stefan Paepke, Dr.         
Principal Investigator: Stefan Paepke, Dr.         
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89075
Contact: Visnja Fink, Dr.         
Principal Investigator: Visnja Fink, Dr.         
GRN Klinik Weinheim Recruiting
Weinheim, Germany
Contact: Lelia Bauer, Dr.         
Principal Investigator: Lelia Bauer, Dr.         
Sponsors and Collaborators
pfm medical ag
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Responsible Party: pfm medical ag
ClinicalTrials.gov Identifier: NCT03868514    
Other Study ID Numbers: P050001 TiLOOP® Bra Pocket
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by pfm medical ag:
breast reconstruction
surgical mesh