The POLBOS-LM trial was in preparation over months between the Steering Committee, Grant-giver, and the Sponsor (ECRI) before start of activities. Start of operations took place at October 2017 with first Ethics Approval achieved after 8 months at Central Hospital of the Internal and Administration Ministry, Warsaw, Poland. All participating sites were active after 18 months from start of activities.
The POLBOS LM trial included 15 sites in 3 countries. Sites were distributed as follows: Poland (9 sites), France (4 sites) and Italy (2 sites).
The first patient was enrolled on 18 October 2018 at Central Hospital of the Internal and Administration Ministry, Warsaw, Poland with Dr. Robert Gil being the site Principal Investigator. Enrolment of all participants, amounting to 130 patients was achieved on 15 April 2020 at Clinique Axium, France with Dr. Luc Maillard being the site Principal Investigator. The achieved rate of enrolment was 0.4 (total number of patients/total number of sites)/months from FPI until LPI).
Enrolment per country was distributed as follows: Poland (65 patients), France (35 patients) and Italy (30 patients). The top 3 enrolling sites in the POLBOS-LM were:
The POLBOS-LM will achieve 1 year of follow-up on Q2 2021 which will be used for reporting the primary endpoint.