UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of safety and effectiveness of the Microwave Surgical Device (Acrosurg.TM) in surgical procedures.
Title of the study (Brief title)	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	Shigeyuki Naka
Organization	Shiga University of Medical Science
Division name	Department of gastrointestinal Surgery, Breast and General Surgery
Address	eta-Tsukinowa-cho, Otsu, Shiga, Japan
TEL	077-548-2238
Email	naka@belle.shiga-med.ac.jp

Public contact
Name of contact person	Shigeyuki Naka
Organization	Shiga University of Medical Science
Division name	Department of gastrointestinal Surgery, Breast and General Surgery
Address	eta-Tsukinowa-cho, Otsu, Shiga, Japan
TEL	077-548-2238
Homepage URL
Email	naka@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science Department of Surgery
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027005