UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021173 |
|---|---|
| Receipt number | R000024233 |
| Scientific Title | New application of Pulsed laser-induced liquid jet system for neuroendoscopic intracerebral hematoma evacuation surgery: a clinical investigation. |
| Date of disclosure of the study information | 2016/02/24 |
| Last modified on | 2016/02/24 11:18:52 |
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Basic information
Public title
New application of Pulsed laser-induced liquid jet system for neuroendoscopic intracerebral hematoma evacuation surgery: a clinical investigation.
Acronym
New application of Pulsed laser-induced liquid jet system for neuroendoscopic intracerebral hematoma evacuation surgery: a clinical investigation.
Scientific Title
New application of Pulsed laser-induced liquid jet system for neuroendoscopic intracerebral hematoma evacuation surgery: a clinical investigation.
Scientific Title:Acronym
New application of Pulsed laser-induced liquid jet system for neuroendoscopic intracerebral hematoma evacuation surgery: a clinical investigation.
Region
| Japan |
Condition
Condition
Intracerebral hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the efficacy and safety of the pulsed laser-induced liquid jet system for the intracerebral hemorrhage surgery, which has already been recognized as a reliable device in pituitary surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Safety evaluation with intraoperative blood loss, operation duration, extent of hematoma evacuation.
Key secondary outcomes
Outcome evaluation with modified Rankin Scale at 6 months.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ICH surgery with
laser-induced liquid jet system
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Intracerebral hemorrhage
2.Disturbance Of Consciousness(Jcs=30-200)
3.With neurological deficits(NISS>4)
4.Hematoma volume (Over 31ml on head CT)
5.Within 72 hours after onset
6.Putaminal hemorrhage, Subcortical hemorrhage, cerebellar hemorrhage
7.PT-INR<1.35 in patients with warfarin administration
8.Over 20 years old
9.No limitation in gender
10.Inpatients
Key exclusion criteria
1.Thalamic hemorrhage, brainstem (pons) hemorrhage
2.3DCTA showing one of the followings; cerebral aneurysms, arteriovenous malformations, dural arteriovenous shunts, sinus thrombosis, moyamoya disease
3.The history of head trauma within 6 months
4.The history of craniotomy within 6 months
5.Novel oral anticoagulants (NOAC) user
6.Women in pregnancy, possibly pregnant, breast feeding, within 28 days postpartum.
7.Uncontrolled mental disorder
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teiji Tominaga |
Organization
Tohoku University Hospital
Division name
Department of Neurosurgery
Zip code
Address
1-1,Seiryo-machi,Aoba-ku,Sendai,Miyagi,980-8574 JAPAN
TEL
022-717-7230
tomi@nsg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Kawaguchi |
Organization
Tohoku University Hospital
Division name
Department of Neurosurgery
Zip code
Address
1-1,Seiryo-machi,Aoba-ku,Sendai,Miyagi,980-8574 JAPAN
TEL
022-717-7230
Homepage URL
kawaguchi@nsg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Scientific Research-KAKENHI
Scientific Research C
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2016 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024233
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
