{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"}],"units":"Participants"}],"description":"Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.","groups":[{"description":"Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy","id":"OG000","title":"Continuum Device"}],"paramType":"NUMBER","populationDescription":"Subjects in whom device placement was attempted","reportingStatus":"POSTED","timeFrame":"At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal","title":"Safety - Creation of a False Passage","type":"PRIMARY","unitOfMeasure":"Events"}