Blue Note Therapeutics Announces Recruitment for Registrational Clinical Trial Studying Effectiveness of Digital Medical Devices in Cancer Patients
Blue Note Therapeutics has announced recruitment for a registrational clinical trial (RCT) to study the effectiveness of two digital, software only, medical devices (SaMD). Both medical devices are anticipated to have an impact on mental and physical health when used adjunctively with multidisciplinary oncology care regimens.
The RCT study population will consist of up to 553 patients living with stage I-III breast cancer or stage I-III non-small cell lung cancer. The study will seek to understand and evaluate the overall study outcomes, including impact on mental and physical health.
Blue Note expects that data from this registrational trial will serve as the basis for the company’s lead prescription digital therapeutic candidate’s regulatory submission to the U.S. Food and Drug Administration.
The multi-center study is currently recruiting. For more information, visit https://ClinicalTrials.gov (NCT04862195).