{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"}],"units":"Participants"}],"description":"As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.","groups":[{"description":"Patients with laryngeal cancer and a total laryngectomy in whom a TE puncture was made and a voice prosthesis was placed by means of the Provox Vega Puncture Set","id":"OG000","title":"Provox Vega Puncture Set"}],"paramType":"NUMBER","populationDescription":"Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.","reportingStatus":"POSTED","timeFrame":"immediate observation during surgery","title":"Success Rate of Procedure","type":"PRIMARY","unitOfMeasure":"Nr part. with succesful insertions"}