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Completed

NCT Number: NCT03868514

Post Market Clinical Follow Up to "Patient Reported Outcome" 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)

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Key information

Conditions

Breast Reconstruction After Mastectomy Breast Cancer Breast Diseases Breast Neoplasm Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien, Vienna, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TiLOOP® Bra Pocket

Device

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

pfm medical gmbh

Industry

Registry information

Official study 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)

Acronym: PRO-Pocket

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Mar 11, 2019
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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