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Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors

NCT02952183 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-11-02

No results posted yet for this study

Summary

Although nerve-sparing surgery has been introduced for female patients with the pelvic tumors, its success rate depends on operators. To achieve consistency of surgical procedure, It is necessary to adopt pelvic autonomic nerve monitoring technique.

The Aims of this study is

1. Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic system.
2. Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I
3. Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)

Conditions

Interventions

DEVICE

PAMS I

After general anesthesia, pressure sensor of PAMS I is placed into bladder, vagina and rectum. Then pressure change is monitored during performing pelvic autonomic nerve dissection. Both PAMS I and IOM will be used for monitoring.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hee Seung Kim, MD · Seoul National University Hospital

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-08-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT02952183 on ClinicalTrials.gov