erve monitoring during robotic radical prostatectomy: a prospective single-arm non-randomized feasibility study

Medtronic, Inc (USA)0 个研究点目标入组 30 人开始时间: 2013年1月18日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Patient is a male between 18 years and 75 years of age
•2. Patient was diagnosed with prostate cancer, undergoing nerve-sparing robotic radical prostatectomy
•3. Patient has been informed of the nature of the study, agrees to its provisions and has provided written consent as approved by the Institutional Review Board (IRB) of the respective investigational site
•4. Patient is able and willing to comply with all study requirements, including the follow-up evaluations and will return to the investigational site(s) for all required office visits
•5. Patient has completed the International Index of Erectile Function (IIEF-5) questionnaire with a score of 17 or higher

•1. Patient has a history of erectile dysfunction associated with neurologic abnormalities
•2. Patient has untreated hypertension (systolic blood pressure > 160mm Hg and/or diastolic blood pressure > 100mm Hg)
•3. Patient has any penile anatomical abnormalities (e.g. penile fibrosis or Peyronie?s disease)
•4. Patient has a penile or urinary sphincter implant
•5. Patient has a history of prior radiation therapy to the pelvic region
•6. Patient is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint
•7. Patient with prior pelvic surgery with a potential for clinical interference with the primary study endpoint

发起方

Medtronic, Inc (USA)