Ignite Creation Date:
2024-05-06 @ 9:20 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02952183
Status:
UNKNOWN
Last Update Posted:
2016-11-02
First Post:
2016-10-17
Brief Title:
Efficacy of Pelvic Autonomic Nerve Monitoring System PAMS I in Female Patients With Pelvic Tumors
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUSION V
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None