Foligno

Researchers are evaluating the ability of MammoWave, an innovative microwave mammogram device, to detect breast lesions in women. This investigation is multicentric, prospective, single-arm, and stratified by breast density. MammoWave uses very low power microwaves instead of traditional x-rays, making it safe for use at any age, including during pregnancy, and allows repeated exams without ionizing radiation exposure. The study aims to confirm MammoWaves effectiveness in detecting both malignant and benign breast lesions, including palpable, non-palpable, and microcalcifications. The study will enroll up to 600 participants across several centers in Italy, Germany, and Spain. It includes two phases a preliminary phase to optimize the imaging algorithm by examining volunteers without lesions, followed by the main phase enrolling women with and without breast lesions. All participants will undergo the MammoWave exam while lying prone on the device, which takes about 10 minutes per breast. The exam includes image acquisition and data processing to generate images and parameters describing breast tissue. Participants will have a standard breast screening alongside the MammoWave exam. Researchers will assess MammoWaves sensitivity and specificity compared to standard diagnostic methods, including mammography, ultrasound, and MRI. Patient satisfaction will also be measured through questionnaires. The primary outcome is the number of true positive results during the MammoWave procedure. The study began in January 2023 and is expected to continue until January 2027, with ongoing monitoring and comparison of results.

Researchers are evaluating MammoWave, a device that uses low-power microwaves instead of X-rays, for early breast cancer detection in women aged 45 to 74. This prospective, multicenter clinical investigation aims to confirm that MammoWave achieves sensitivity greater than 75% and specificity greater than 90% for breast cancer detection among 10,000 volunteers undergoing regular screening programs. The study compares MammoWave results with conventional breast examination methods including mammograms and other radiological or histological tests. Participants will undergo both the standard breast screening exams and the MammoWave exam. The MammoWave exam involves lying prone on a bed while the device collects microwave data from both breasts over about 8 minutes. Data processing uses a special imaging algorithm to produce microwave images and classification results indicating suspicious or non-suspicious findings. The study device contains the same hardware as a CE-marked version but uses updated software. During the study, participants will have conventional breast exams along with the MammoWave exam. Researchers will evaluate MammoWaves sensitivity and specificity during the procedure and analyze detection rates, recall rates, and positive predictive values at baseline. Volunteers will also complete satisfaction questionnaires. The study will monitor breast cancer detection by histological type, size, and breast density. The trial is expected to run until December 2026.

This research aims to identify medium-term factors that influence recovery for patients with Severe Acquired Brain Injuries. It also seeks to develop a continuous system to assess the quality of care provided by rehabilitation units treating these patients. The study focuses on understanding key outcomes important to rehabilitation success. Data will be collected from each participating rehabilitation unit, including information about their structure and organization. Detailed patient data will be gathered upon admission to these units and then re-evaluated four months after their acute brain injury event. Statistical models will be used to predict the likelihood of achieving three key rehabilitation goals removal of tracheostomy tubes, trunk control, and full feeding by mouth. Participants will be adults admitted to these specialized rehabilitation units between July 2021 and December 2023. Patients admitted more than 14 weeks after their acute injury will not be included. Researchers will monitor patients for up to four months post-injury to evaluate the main outcomes. The study will help understand patient progress and care quality in these rehabilitation settings.