Unique ID issued by UMIN | UMIN000033394 |
---|---|
Receipt number | R000038073 |
Scientific Title | Neurosurgery with middleware which enables integration of intraoperative information from each medical instrument |
Date of disclosure of the study information | 2018/07/17 |
Last modified on | 2020/01/17 10:18:25 |
Neurosurgery with middleware which enables integration of intraoperative information from each medical instrument
Neurosurgery with middleware which enables integration of intraoperative information
Neurosurgery with middleware which enables integration of intraoperative information from each medical instrument
Neurosurgery with middleware which enables integration of intraoperative information
Japan |
brain tumor
Neurosurgery |
Others
NO
The narrative objects is to validate the safety and efficacy of the surgery with middleware "OPeLiNK" which enables integration of intraoperative information from various medical instrument.
Safety,Efficacy
Questionnaire from user of "OPeLiNK"
Postoperative neurological deficits, postoperative bleeding, complication of craniotomy such as infection
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Other |
Surgery using "OPeLiNK"
16 | years-old | <= |
Not applicable |
Male and Female
1. Patients who are equal or over 16 years old
2. Patients whose preoperative diagnosis are primary or metastatic brain tumor
3. Patients who agree with this clinical study
4. Patients who do not need agreement individually and who do not reject this clinical study
1. Patients who can not take MRI
2. Patients with severe heart, renal, hepatic disorder
3. Patients who have huge tumor
4. Patients who have deep-seated tumor
5. Patients who can not agree because of aphasia
6. Patients who had received chemoradiotherapy
7. Patients who have another malignant disease
8. Patients who are judged to be inappropriate in this clinical study
80
1st name | Tetsuyoshi |
Middle name | |
Last name | Horiuchi |
Shinshu University School of Medicine
Department of Neurosurgery
390-8621
Asahi 3-1-1, Matsumoto, Nagano
0263372690
yufujii@shinshu-u.ac.jp
1st name | Yu |
Middle name | |
Last name | Fujii |
Shinshu University School of Medicine
Department of Neurosurgery
390-8621
Asahi 3-1-1, Matsumoto, Nagano
0263372690
yufujii@shinshu-u.ac.jp
Japan Agency for Medical Research and Development
none
Self funding
the Committee for Medical Ethics of Shinshu University School of Medicine
Asahi 3-1-1, Matsumoto, Nagano
0263372572
byouin_soumu@gm.shinshu-u.ac.jp
NO
2018 | Year | 07 | Month | 17 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 06 | Month | 04 | Day |
2018 | Year | 06 | Month | 06 | Day |
2018 | Year | 07 | Month | 17 | Day |
2023 | Year | 03 | Month | 31 | Day |
2018 | Year | 07 | Month | 15 | Day |
2020 | Year | 01 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038073
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |