UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023758 |
|---|---|
| Receipt number | R000027005 |
| Scientific Title | Evaluation of safety and effectiveness of the Microwave Surgical Device (Acrosurg.TM) in surgical procedures. |
| Date of disclosure of the study information | 2016/08/25 |
| Last modified on | 2016/09/08 14:10:07 |
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Basic information
Public title
Evaluation of safety and effectiveness of the Microwave Surgical Device (Acrosurg.TM) in surgical procedures.
Acronym
Evaluation of safety and effectiveness of the Microwave Surgical Device in surgical procedures.
Scientific Title
Evaluation of safety and effectiveness of the Microwave Surgical Device (Acrosurg.TM) in surgical procedures.
Scientific Title:Acronym
Evaluation of safety and effectiveness of the Microwave Surgical Device in surgical procedures.
Region
| Japan |
Condition
Condition
Disease for Digestive surgery (esophagus, stomach, colorectum, pancreas, liver and hernia) and Breast surgery.
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and effectiveness of the Microwave Surgical Device (Acrosurg.TM) in digestive surgery (esophagus, stomach, colorectum, pancreas, liver and hernia) and breast surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemorrhagic adverse events during and after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using Microwave Surgical Device (Acrosurg.TM) in digestive surgery (esophagus, stomach, colorectum, pancreas, liver and hernia) and breast surgery instead of the ordinary energy devices.
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) PS (ECOG Performance Status Scale):0-1
2) BMI (body mass index) <=30
3) Patients who have no severe disorder of blood coagulation and organ failure.
4) Patients in case that the person or legal representative can provide written informed consent.
Key exclusion criteria
1) Patients with serious concomitant diseases such as ischemic heart disease or arrhythmia to need treatment, myocardial infarction developed within 6 months, liver failure, diabetes having poor control or bleeding tendency.
2) Patients with infectious disease or patients who is possibly infected having fever.
3) Patients who have the following examination data.
1. WBC<3,000/mm3
2. Plt. <50,000/mm3
3. AST >100 IU/L, ALT>100IU/L
4. T-Bil >3.0 g/dl
5. CRE >2.0 mg/dl
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Naka |
Organization
Shiga University of Medical Science
Division name
Department of gastrointestinal Surgery, Breast and General Surgery
Zip code
Address
eta-Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2238
naka@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Naka |
Organization
Shiga University of Medical Science
Division name
Department of gastrointestinal Surgery, Breast and General Surgery
Zip code
Address
eta-Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2238
Homepage URL
naka@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
NIKKISO CO., LTD.
Organization
Division
Category of Funding Organization
Profit 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 | 08 | Month | 25 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 25 | 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 | 08 | Month | 25 | Day |
Last modified on
| 2016 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027005
