Outcome measurements
bleeding
SECONDARY, EVENT, BLEEDING
The primary efficacy end point was the mean number of coagulations (performed with hemostatic forceps), as determined by the third-party evaluation committee.The secondary efficacy end points were the mean number of coagulations (determined by the operator), time from confirmation of a blood oozing event to the completion of hemostasis (determined by the third-party evaluation committee and the operator), time from the initiation to the completion of ESD (determined by the operator), and the time from coagulation to the completion of ESD (determined by the operator).Secondary end points for the TDM-621 group also included the number of sites in which hemostasis was achieved using TDM-621 alone, the number of sites in which bleeding recurred after achieving hemostasis, and the number of times those sites received additional treatment for hemostasis. The hemostasis and operation times were determined by the third-party evaluation committee and the operator. The amount of TDM-621 applied and the operability for the application of TDM-621 based on the operator's judgment were also evaluated in each case, based on 2 criteria: “it could be applied appropriately to the target site” and “it could not be applied appropriately to the target site.”