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

Breast Cancer Clinical Trial

— PRO-Pocket  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868514
• Other study ID #: P050001 TiLOOP® Bra Pocket
• Status: Completed
• Start date: July 4, 2019
• Est. completion date: November 15, 2023

Study information

• Verified date: November 2023
• Source: pfm medical ag
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: November 15, 2023
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases
• Breast Neoplasm
• Breast Neoplasms
• Breast Reconstruction After Mastectomy

Intervention

Device:
• TiLOOP® Bra Pocket
Primary or secondary breast reconstruction following mastectomy with titanised polypropylene mesh TiLOOP® Bra Pocket

Locations

Country	Name	City	State
Austria	Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien	Vienna
Germany	DRK Kliniken Westend	Berlin
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Kliniken Essen Mitte; Evang. Huyssens-Stiftung	Essen
Germany	Agaplesion Markus Krankenhaus	Frankfurt
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Klinikum rechts der Isar der Technischen Universität München	Munich
Germany	Rotkreuzklinikum München	Munich
Germany	Universitätsklinikum Ulm	Ulm
Germany	GRN Klinik Weinheim	Weinheim

Sponsors (1)

Lead Sponsor	Collaborator
pfm medical ag

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life - Patient reported outcome	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	Quality of Life - Patient reported outcome	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
Secondary	Complication rate	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
Secondary	Cosmetic outcome	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

External Links

•   pfm medical study information