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Study of Endorectal Cooling During RARP to Minimize Trauma and Promote Earlier Return to Continence

NCT01920035 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-08-20

No results posted yet for this study

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 protective urinary pads), compared with standard of care in men presenting for RARP.

Conditions

  • Incontinence

Interventions

DEVICE

UroCool (Local cooling/hypothermia)

These patients will receive the UroCool device which will be inserted just prior to RARP surgery. The UroCool device will be used to effect localized cooling/hypothermia of the pelvic region prior to and during RARP surgery. It will be removed at the end of surgery.

Sponsors & Collaborators

  • ZOLL Circulation, Inc., USA

    lead INDUSTRY

Principal Investigators

  • Thomas Ahlering, MD · UC Irvine

  • Anthony M Mullin, MD, MDDR · Philips Healthcare/InnerCool BU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01920035 on ClinicalTrials.gov