Northbrook

Researchers are evaluating the Gixam device to see if it can effectively identify adults aged 45 to 84 who have pre-cancer or cancer in the colon and rectum despite having a negative result on a Fecal Immunochemical Test FIT. This study focuses on people considered at average risk for colorectal cancer and aims to assess both the devices accuracy and safety compared to standard screening methods. Participants in this study will undergo three procedures the Gixam test, a FIT at home with stool sample mailing to a lab, and a standard screening colonoscopy which serves as the gold standard for comparison. All participants will receive the same interventions to ensure consistent evaluation of the Gixam system. During the study, participants will complete the Gixam test and FIT, followed by a screening colonoscopy. Researchers will monitor safety from enrollment through 30 days after the study ends and assess efficacy based on findings during this period. The main outcomes include the devices ability to detect colorectal neoplasia and its safety profile. Participation involves multiple visits and procedures over approximately one month.

This trial evaluates the safety and effectiveness of ARTIA Reconstructive Tissue Matrix in adult women undergoing immediate, two-stage implant-based breast reconstruction following mastectomy. The study focuses on participants having either unilateral or bilateral mastectomy and aims to assess outcomes related to breast reconstruction complications and participant satisfaction. Participants will receive breast reconstruction using the ARTIA Tissue Matrix device in a two-stage prepectoral implant-based procedure. The study is open-label, non-randomized, and conducted across multiple centers. The follow-up includes monitoring for major complications after the first stage and adverse events for up to approximately 36 months. Throughout the study, participants will be monitored for complications related to breast reconstruction, reconstructive failure, capsular contracture, and changes in satisfaction with breasts using the BREAST-Q score. Safety assessments and adverse event tracking will continue up to three years. The total study duration extends until February 2031, with primary outcome assessments at 18 months and secondary measures up to 36 months.

Researchers are evaluating the differences between subcutaneous SC and intravenous IV administration of frexalimab in adults aged 18 to 60 years with relapsing multiple sclerosis RMS and non-relapsing secondary progressive multiple sclerosis nrSPMS. This Phase 3, randomized, open-label study aims to compare the pharmacokinetics, safety, and efficacy of these two methods of delivering frexalimab over a one-year period. Participants include males and females diagnosed with MS who meet specific clinical criteria related to their disease type and progression. Participants will be randomly assigned to receive frexalimab either as an SC injection every 4 weeks using a home self-administration on-body delivery system after training and agreement starting from Part B or as an IV infusion every 4 weeks. The treatment duration covers 48 weeks for the first two parts of the study, with an optional third part continuing until the start of a long-term safety study. Regular visits occur monthly between weeks 4 and 24, then less frequently up to the end of the study, with follow-up visits for those who discontinue treatment early. During the study, participants will attend up to 17 scheduled visits and undergo assessments including MRI scans with contrast, blood tests to measure drug levels and immune responses, and evaluations of disability progression. Researchers will monitor adverse events, the presence of antibodies to the drug, and participant preferences for SC versus IV administration. Follow-up continues for six months after treatment ends to assess long-term safety and outcomes. The study collects data on pharmacokinetics and clinical effects at multiple timepoints up to week 96 and beyond for some participants.