NCT03868514

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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 4, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

March 6, 2019

Last Update Submit

November 15, 2023

Conditions

Breast Reconstruction After MastectomyBreast NeoplasmBreast CancerBreast Diseases

Keywords

breast reconstructionsurgical meshsynthetic meshpatient reported outcomebreast cancermesh

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Quality of Life - Patient reported outcome

    6 and 24 months after study treatment

  • Complication rate

    6, 12 and 24 months after study treatment

  • Cosmetic outcome

    6, 12 and 24 months after study treatment

Study Arms (1)

TiLOOP Bra Pocket

Medical Device

Device: TiLOOP® Bra Pocket

Interventions

TiLOOP® Bra PocketDEVICE

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

TiLOOP Bra Pocket

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with indicated implant based breast reconstruction after mastectomy.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien

Vienna, 1090, Austria

Location

Vivantes Klinikum Am Urban

Berlin, 10967, Germany

Location

DRK Kliniken Westend

Berlin, 14050, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Kliniken Essen Mitte; Evang. Huyssens-Stiftung

Essen, 45136, Germany

Location

Agaplesion Markus Krankenhaus

Frankfurt, 60431, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Rotkreuzklinikum München

Munich, 80637, Germany

Location

Klinikum rechts der Isar der Technischen Universität München

Munich, 81675, Germany

Location

Universitätsklinikum Ulm

Ulm, 89075, Germany

Location

GRN Klinik Weinheim

Weinheim, Germany

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsBreast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 11, 2019

Study Start

July 4, 2019

Primary Completion

June 22, 2022

Study Completion

November 15, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)DE(11)