We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952183
Recruitment Status : Unknown
Verified October 2016 by Hee Seung Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hee Seung Kim, Seoul National University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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)

Condition or disease Intervention/treatment Phase
Cervical Cancer Uterine Cancer Ovarian Cancer Device: PAMS I Not Applicable

Detailed Description:

After surgery for pelvic tumor, most of patients complain voiding dysfunction, defecation dysfunction and sexual dysfunction which lead to decrease quality of life. Recently, nerve-sparing surgery has been introduced. But it is difficult to establish standard surgical procedure for nerve-sparing. And it is the concern that performing nerve sparing surgery may reduce radicality of surgery which influence prognosis.

Through pelvic autonomic nerve monitoring system (PAMS I), this trial is expected to raise the possibility of nerve-sparing with maintaining radicality of surgery.

Pressure sensor of PAMS I and needle prove of IOM are very thin and these instruments have been used clinically. Taking this into consideration, additional risk by nerve monitoring is considered to be minimal.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Exploratory Study for Evaluating the Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors (FUSION Trial V)
Study Start Date : July 2015
Estimated Primary Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: PAMS I
During operation, autonomic nerve monitoring will be performed by PAMS I which is composed of two urodynamic systems.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Evaluating efficacy of PAMS I by comparison with IOM [ Time Frame: Intraoperative ]

    Comparision pressure change on PAMS I with nerve conduction on IOM

    i) PAMS I (+) & IOM (+): nerve-sparing

    ii) PAMS I (-) & IOM (-): nerve damage

    iii) PAMS I (+) & IOM (-) or PAMS I (-) & IOM (+): intermediate



Secondary Outcome Measures :
  1. Evaluation of Quality of life. [ Time Frame: Preoperative, 3 months after surgery ]
    Voiding/Defecation/Sexual function

  2. Time period for recovering normal voiding function [ Time Frame: postoperative (up to 6 month) ]
    Check residual urine. Keep CIC until residual urine < 100cc

  3. Urodynamic test [ Time Frame: Preoperative, 3 months after surgery ]
  4. Anorectal manometry [ Time Frame: Preoperative, 3 months after surgery ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female, Age ≥ 18 years

  • Patients with pelvic malignant tumor who need surgery.

    • Gynecologic cancer; cervical cancer, uterine cancer, ovarian cancer
    • Colorectal cancer
    • Pelvic sarcoma and metastatic pelvic malignant tumor
  • Patients who signed an approved informed consent.

Exclusion Criteria:

  • Female, Age < 18 years
  • Patients with pelvic malignant tumor, but surgery is not indicated.
  • Patients who refused to sign informed consent
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952183


Contacts
Layout table for location contacts
Contact: Hee Seung Kim, MD 82-2-2072-4863 bboddi0311@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seungmee Lee, MD    82-2-2072-2821    yumenoarika@naver.com   
Contact: Hee Seung Kim, MD    82-2-2072-4863    bboddi0311@gmail.com   
Principal Investigator: Hee Seung Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hee Seung Kim, MD Seoul National University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hee Seung Kim, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02952183    
Other Study ID Numbers: 2015-2092
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hee Seung Kim, Seoul National University Hospital:
Autonomic nerve monitoring
Nerve-sparing surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Uterine Diseases