EPAD Monitoring of Patients Undergoing Robotic Assisted Laparoscopic Genitourinary Surgery

NCT03319407 | Terminated Results FDA Device

• 1 other identifier: 17-006546
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Somatosensory Evoked Potential Monitoring

  Recording of somatosensory evoked potential in patients undergoing genitourinary surgery

  in the first 24 hours of postoperative period

Study Arms (1)

Observation

OTHER

All participants will be monitored with EPAD system

Device: EPAD monitoring system

Interventions

EPAD monitoring system DEVICE

EPAD system will be used as part of routine care

Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo robotic assisted laparoscopic genitourinary surgery
• Patients who are scheduled to have EPAD monitoring as part of their clinical care intraoperatively

You may not qualify if:

• Patients with previous history of polyneuropathy, carpal tunnel, ulnar neuropathy, or similar neurological deficiencies

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Robert L. McClain, M.D.
• Organization: Mayo Clinic

Mcclain.Robert@mayo.edu

904-956-1728

Study Officials

• Robert McClain, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 24, 2017
• Study Start: October 5, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: April 12, 2023
• Results First Posted: October 30, 2019

Record last verified: 2023-04

Locations

US (1)