Cervical CancerFUSION VNCT02952183
Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors
A study testing PAMS I in people with Cervical Cancer and Uterine Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Uterine Cancer, Ovarian Cancer
- What is being tested?
- PAMS I
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Female, Age < 18 years
- Patients with pelvic malignant tumor, but surgery is not indicated.
- Patients who refused to sign informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Seungmee Lee, MD, 82-2-2072-2821, yumenoarika@naver.com
Hee Seung Kim, MD, 82-2-2072-4863, bboddi0311@gmail.com
About this study
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)
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)
Read the 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.
- Conditions
- Cervical Cancer, Uterine Cancer, Ovarian Cancer
- Being tested
- PAMS I
- Keywords
- Autonomic nerve monitoring, Nerve-sparing surgery
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAMS IDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PAMS I | Experimental | During operation, autonomic nerve monitoring will be performed by PAMS I which is composed of two urodynamic systems. Receives: Device: PAMS I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating efficacy of PAMS I by comparison with IOM
Comparision pressure change on PAMS I with nerve conduction on IOM
- PAMS I (+) \& IOM (+): nerve-sparing ii) PAMS I (-) \& IOM (-): nerve damage iii) PAMS I (+) \& IOM (-) or PAMS I (-) \& IOM (+): intermediate
Measured: Intraoperative
Secondary outcomes (4)
Evaluation of Quality of life.
Voiding/Defecation/Sexual function
Measured: Preoperative, 3 months after surgery
Time period for recovering normal voiding function
Check residual urine. Keep CIC until residual urine < 100cc
Measured: postoperative (up to 6 month)
Urodynamic test
Measured: Preoperative, 3 months after surgery
Anorectal manometry
Measured: Preoperative, 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startJul 2015
- Primary completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Seung Kim, Seoul National University Hospital
- Investigators
- Hee Seung Kim, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952183
- Sponsor's protocol ID
- 2015-2092
- Acronym
- FUSION V
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02952183
- Acronym / sponsor ID
- FUSION V / 2015-2092
- Conditions
- Cervical Cancer, Uterine Cancer, Ovarian Cancer
- Keywords
- Autonomic nerve monitoring, Nerve-sparing surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2018 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAMS I | Experimental | Device: PAMS IDuring operation, autonomic nerve monitoring will be performed by PAMS I which is composed of two urodynamic systems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female, Age ≥ 18 years
- Patients with pelvic malignant tumor who need surgery.
- Patients who signed an approved informed consent.
Key exclusion criteria (3 listed)
- Female, Age < 18 years
- Patients with pelvic malignant tumor, but surgery is not indicated.
- Patients who refused to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAMS IAfter 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. | Device | PAMS I |
Primary outcome
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
4 secondary outcomes
Evaluation of Quality of life.
Time frame: Preoperative, 3 months after surgery
Time period for recovering normal voiding function
Time frame: postoperative (up to 6 month)
Urodynamic test
Time frame: Preoperative, 3 months after surgery
Anorectal manometry
Time frame: Preoperative, 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Seung Kim, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAMS I in people with Cervical Cancer and Uterine Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Seung Kim, MD (82-2-2072-4863, bboddi0311@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating efficacy of PAMS I by comparison with IOM (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.