Thanks to SME Instrument Phase 2 Grant, we will expand clinical trials in Hospitals across Europe with the aim of confirming the results obtained in the ongoing clinical trials. These new Hospitals will include:
- Humanitas Research Hospital, Milano, Italy;
- Ospedale Policlinico San Martino, Genova, Italy;
- Hospital Virgen de la Salud, Toledo, Spain;
- Universitätsklinikum Erlangen, Germany.
Clinical trials will be based on the protocol "A multicentric, single arm, prospective, stratified clinical investigation to evaluate the ability of MammoWave in breast lesions detection", which has been finalized in collaboration with MTA - Medical Trials Analysis (https://www.mtagroup.net/).
The clinical study "Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection (DE-17-17)" has now been included on the Clinical Trials registry ClinicalTrials.gov
ClinicalTrials.gov is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trials database. This registration represents a milestone for UBT Srl and it has been achieved thanks to all the Clinical Investigators, who have supported MammoWave project: Michele Duranti, Riccardo Loretoni, Cristina Romero Castellano, Daniela Bernardi, Alberto Tagliafico, Massimo Calabrese, Matthias Dietzel.
Authorization to start the trial has been already secured from the Ethical Committees of Humanitas Research Hospital, Milano, Italy; Ospedale Policlinico San Martino, Genova, Italy; Hospital Virgen de la Salud, Toledo, Spain; University Hospital Erlangen, Erlangen, Germany and from the Italian, Spanish and German authorities.
MammoWave has been already installed at Hospital Virgen de la Salud, Toledo, Spain, at Ospedale Policlinico San Martino, Genova, Italy, at Ospedale Humanitas, Milano, Italy. The correspondent Site Initiation Visits have been already performed and the trials are ongoing.