Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors (FUSION V)
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|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
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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
- Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic system.
- Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I
- 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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
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.
- 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
- Evaluation of Quality of life. [ Time Frame: Preoperative, 3 months after surgery ]Voiding/Defecation/Sexual function
- Time period for recovering normal voiding function [ Time Frame: postoperative (up to 6 month) ]Check residual urine. Keep CIC until residual urine < 100cc
- Urodynamic test [ Time Frame: Preoperative, 3 months after surgery ]
- Anorectal manometry [ Time Frame: Preoperative, 3 months after surgery ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- Female, Age < 18 years
- Patients with pelvic malignant tumor, but surgery is not indicated.
- Patients who refused to sign informed consent
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
|Contact: Hee Seung Kim, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Seungmee Lee, MD 82-2-2072-2821 email@example.com|
|Contact: Hee Seung Kim, MD 82-2-2072-4863 firstname.lastname@example.org|
|Principal Investigator: Hee Seung Kim, MD|
|Principal Investigator:||Hee Seung Kim, MD||Seoul National University Hospital|
|Responsible Party:||Hee Seung Kim, Associate Professor, Seoul National University Hospital|
|Other Study ID Numbers:||
|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|
Autonomic nerve monitoring
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Genital Neoplasms, Female