Status:
COMPLETED
Study of Endorectal Cooling During RARP to Minimize Trauma and Promote Earlier Return to Continence
Lead Sponsor:
ZOLL Circulation, Inc., USA
Conditions:
Incontinence
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Localized cooling/hypothermia using the UroCool System during robotic-assisted radical prostatectomy (RARP) surgery results in an improved overall return to continence, (defined as not wearing any pro...
Detailed Description
This study will assess the use of an endorectal cooling device, UroCool, to achieve controlled, local hypothermia of the pelvis. The study will evaluate the safety and effectiveness of the device in i...
Eligibility Criteria
Inclusion
- Patient is male and a candidate for robotic assisted radical prostatectomy (RARP) for the treatment of prostate cancer
- Patient is over eighteen (\>18) years of age
- Patient reads, understands and speaks English fluently (U.S. Sites only)
- Subject understands and agrees to all pre-operative preparation procedures including a "self-administered" fleet enema
- Subject understands study procedures, risks of such procedures and is willing to comply with all study procedures
- Patient is willing and able to comply with all post-surgical milestones including completing and returning post-surgery follow up questionnaires at specified intervals over a 12 month period
- Subject agrees to participate in the study and is willing to sign the written informed consent per the enrolling site's institutional procedure
Exclusion
- Presents with baseline or has a history of urinary incontinence
- Rectal or GI pathology deemed unsuitable for placement of the treatment device by the examining physician
- Prior extensive pelvic surgery such as low anterior resection, abdominoperineal resection, or proctocolectomy continent stool pouch, or any other extensive abdominopelvic surgery that would render the patient a high-risk for complications as deemed by the surgeon
- History of prior treatment of any kind for prostate cancer; e.g. radiation therapy, cryotherapy, high-intensity focused ultrasound (HIFU), hormonal or chemotherapy
- Prior intra-operative injuries (for example: rectal injury)
- Inadequate hemostasis
- Serious concurrent medical condition likely to result in death during the next 12 months. Any other acute or chronic condition which the Investigator believes will unacceptably increase the risk of study participation or interfere with study procedures and assessments.
- Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study or planned to be enrolled in another study of prostate therapy.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01920035
Start Date
May 1 2013
End Date
December 1 2014
Last Update
August 20 2020
Active Locations (3)
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1
City Of Hope
Duarte, California, United States, 91010
2
Swedish Medical Center
Seattle, Washington, United States, 98122
3
St. Antonius-Hospital Gronau GmbH
Gronau, Germany, 48599