5 results
The primary objective of this clinical investigation is to investigate the effect of the Provox Luna system on compliance of HME use. Compliant use is defined as daily use of an HME for at least 20 hours per day 86% (=24/28; each study period is 4…
The objective of this clinical investigation is to evaluate the clinical performance of Provox Luna in comparison to the usual care of the patient.
Phase 2:• To assess the safety, tolerability, systemic exposure, and efficacy of AMT-101 in subjects with chronic antibiotic-resistant pouchitis• To select an AMT-101 dose for Phase 3Phase 3:Co-primary Objectives:• To determine the effect of AMT-101…
To evaluate the effects of AMT-101 in combination with adalimumab on UC disease activity as measured by symptoms, endoscopy, histology, and biomarkers. To evaluate the safety and tolerability of oral AMT-101 over 8 weeksTo assess the PK parameters…
Primary objectiveDemonstrate that the SENSA Bladder Sensor can detect the bladder before urination among its adult intended user Secondary objective(s)1) Collect real-life data to evaluate the clinical performance of the SENSA Bladder Sensor, the…