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NCT03319407 Clinical Trial

EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery

Surgery Clinical Trial

Official title:
EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03319407
Other study ID # 17-006546
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 5, 2017
Est. completion date December 30, 2018

Study information
Verified date April 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants to be enrolled in this study will have been scheduled to have laparoscopic genitourinary surgery and EPAD monitoring as part of their clinical care intraoperatively. Patients scheduled for genitourinary surgery are often at risk for developing nerve injuries due to intraoperative positioning. Somatosensory evoked potential devices (SSEP) are commonly used to detect pending injury to peripheral nerves. The purpose of the present study is to use SSEP monitoring to determine the incidence and potential causes of significant changes in SSEP waveforms and correlate these changes with neurologic status of the brachial plexus after robotic surgery.

Recruitment information / eligibility
Status Terminated
Enrollment 21
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients scheduled to undergo robotic assisted laparoscopic genitourinary surgery - Patients who are scheduled to have EPAD monitoring as part of their clinical care intraoperatively Exclusion Criteria: • Patients with previous history of polyneuropathy, carpal tunnel, ulnar neuropathy, or similar neurological deficiencies

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• EPAD monitoring system
EPAD system will be used as part of routine care

Locations
Country Name City State
United States Mayo Clinic Florida Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Somatosensory Evoked Potential Monitoring Recording of somatosensory evoked potential in patients undergoing genitourinary surgery in the first 24 hours of postoperative period
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