Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket) (PRO-Pocket)
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|ClinicalTrials.gov Identifier: NCT03868514|
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : August 18, 2020
|Condition or disease||Intervention/treatment|
|Breast Reconstruction After Mastectomy||Device: TiLOOP® Bra Pocket|
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|
|Estimated Enrollment :||300 participants|
|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|
TiLOOP Bra Pocket
Device: TiLOOP® Bra Pocket
Primary or secondary breast reconstruction following mastectomy with titanised polypropylene mesh TiLOOP® Bra Pocket
- 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.
- 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.
- 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).
- 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).
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
|Contact: Katja Klein||0049 22369641 ext email@example.com|
|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.|
|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.|
|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.|
|Greifswald, Germany, 17475|
|Heidelberg, Germany, 69120|
|Contact: Jörg Heil, Prof. Dr.|
|Principal Investigator: Jörg Heil, Prof. Dr.|
|Munich, Germany, 80637|
|Klinikum rechts der Isar der Technischen Universität München||Recruiting|
|Munich, Germany, 81675|
|Contact: Stefan Paepke, Dr.|
|Principal Investigator: Stefan Paepke, Dr.|
|Ulm, Germany, 89075|
|Contact: Visnja Fink, Dr.|
|Principal Investigator: Visnja Fink, Dr.|
|GRN Klinik Weinheim||Recruiting|
|Contact: Lelia Bauer, Dr.|
|Principal Investigator: Lelia Bauer, Dr.|