The CROES is an official organ within the Endourological Society

The CROES is an official organ within the Endourological Society responsible for organising, structuring and favouring a global network on endourological research. This research received no other specific grant from any funding agency in the public, commercial or not-for-profit sectors. Benefits and harms There are no benefits for the patients that participate in this study. Patients need to Abiraterone side effects be informed about the risks of surgery and the procedure. Because the IRE technology is relatively new, there may be potential risks and side effects that are unknown at this time. A clinical risk analysis has been prepared which describes the hazards

associated with the use of the device and the associated clinical risks associated with the procedure (eg, general anaesthesia) along with the mitigations available to reduce this hazard. Potential risks associated with the use of IRE include, but are not limited to the list in online supplementary appendix 2. Other accepted focal treatments for prostate cancer, such as percutaneous prostate cryoablation, have limitations such

as variable damage at the lesion margins, injury to adjacent structures such as the rectum, urethra and neurovascular bundle, and long procedure times. These characteristics have limited the widespread acceptance of this modality despite certain demonstrated advantages over the more traditional treatments of radiation and RP. Research has been shown to have significant advantages in ablating hepatic tissue, such as rapid lesion creation, rapid lesion resolution, sparing of structures such as

vessels and bile ducts, and uniform destruction throughout the IRE lesion.11 It is theorised that these advantages will also apply to use in the prostate. Data and Safety Monitoring Board The Data and Safety Monitoring Board (DSMB) will act in an independent, expert and advisory capacity to monitor participant safety, and evaluate the efficacy and the overall conduct of the study. The responsibilities of the DSMB are to monitor safety data on a regular basis and, if required, on ad hoc basis GSK-3 to guide recommendation for continuation of the study or early termination because of clear harm. Furthermore to monitor efficacy data on a regular basis to guide recommendations for continuation of the study or early termination because of clear harm or futility, and to evaluate the overall conduct of the trial, including (1) monitoring of compliance with the protocol by participants and investigators; (2) monitoring of recruitment figures and losses to follow-up; (3) monitoring planned sample size assumptions; (4) reports on data quality; (5) reports on completeness of data and (6) monitoring of continuing appropriateness of patient information. The charter is included in online supplementary appendix 3. Compensation for injury The investigator has a liability insurance that is in accordance with article 7, subsection 6 of the WMO.

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