UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study of safety and usefulness of a new miniature wide-field camera for laparoscopic colorectal surgery.
Acronym	A prospective study of safety and usefulness of a new miniature wide-field camera for laparoscopic colorectal surgery.
Scientific Title	A prospective study of safety and usefulness of a new miniature wide-field camera for laparoscopic colorectal surgery.
Scientific Title:Acronym	A prospective study of safety and usefulness of a new miniature wide-field camera for laparoscopic colorectal surgery.
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and usefulness of the miniature wide-field camera system.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	All adverse events during perioperative time.
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	The participation start date is the time of consent to this research, observation start time is the start of observation, and observation end time is the time of the end of surgery. In the case of Pre-observation period: Up to one week from acquisition of consent to laparoscopic surgery Research intervention period: the day when the laparoscopic assisted surgery was performed Post-observation period: 28 days from the day of surgery
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients whose age at agreement acquisition is from 20 years old to 80 years old. 2. Patients who are scheduled to undergo laparoscopic assisted colorectal resection at our hospital due to hospitalization (degree of progression of colorectal cancer does not matter). 3. Patient whose PS (ECOG) are either 0 or 1. 4. Patients whose main organ function are maintained. Fulfill all of the following laboratory findings. (Use the latest inspection value within 30 days of registration) 1.T.bil less than 1.5 mg/dL 2.AST(GOT) less than 200 IU/L 3.ALT(GPT) less than 200 IU/L 4.Cr less than 1.2 mg/dL 5. Patients who obtain written consent regarding the participation of this study.
Key exclusion criteria	1. Patients with a history of abdominal surgery 2. Patients who are undergoing or plan to conduct anticoagulation therapy before and during surgery 3. Patients with a history of ischemic heart disease, cerebral infarction. 4. Patients judged by the research doctor to be inappropriate for participation in this study.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Ohdan
Organization	Graduate school of Hiroshima University
Division name	Department of Gastroenterological and Transplant Surgery, Applied Life Sciences, Institute of Biomedical & Health Sciences
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, JAPAN
TEL	082-257-5222
Email	hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Shoichiro Middle name Last name Mukai
Organization	Graduate school of Hiroshima University
Division name	Department of Gastroenterological and Transplant Surgery, Applied Life Sciences, Institute of Biomed
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, JAPAN
TEL	082-257-5222
Homepage URL
Email	mukais@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	SHARP corporation
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	Hiroshima University Hospital Clinical Research Ethics Committee
Address	1-2-3 Kasumi Minamiku Hiroshima
Tel	082-257-5947
Email	iryo-seisaku@office.hiroshima-u.ac.jp

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	2017 Year 02 Month 21 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	Completed
Date of protocol fixation	2017 Year 02 Month 15 Day
Date of IRB	2017 Year 01 Month 24 Day
Anticipated trial start date	2017 Year 02 Month 21 Day
Last follow-up date	2017 Year 07 Month 27 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 07 Month 27 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2019 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029965