4 results
Primary Safety Endpoint:Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between deviceā¦
The primary objective of the PASSENGER study is to investigate any relationship between changes in SonR1 augmentation and a change in patients* exercise capacity as assessed by the 6 Minute Walk Test.
To directly correlate CLE images with histopathology, and identify and define CLE characteristics of normal urothelium, benign bladder urothelium, and bladder tumors (low-grade, high-grade NMIBC or CIS) of the lower urinary tract.
Primary Objective: Therapeutic effect of electrical stimulation. Secondary Objective(s): (i) Side effects of electrical stimulation(ii) Effect on quality of life (iii) Effect of electrical stimulation on inflammatory and histologic parameters.