UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intraoperative lens cleaning system for Laparoscope :a prospective randomized controlled study.
Title of the study (Brief title)	Laparoscopic lens cleaning system (LCS) study.
Region	Japan

Condition
Condition	Colorectal disease, Gastric disease
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate usefulness of newly developed laparoscopic lens cleaning system during colorectal and gastric procedure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time per hour required for laparoscopic lens cleaning during operations.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Laparoscopic lens cleaning system group
Interventions/Control_2	Conventional laparoscope group
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	20 years or older. Patients who can fuller understand the contents of the study. The consent is obtained from the patients.
Key exclusion criteria	Less than 20 years old. Patients who cannot fuller understand study contents. The consent is not obtained from the patients. Patients who do not undergo laparoscopic surgery for any reason. Any other case who is regarded inadequate for study enrollment by investigators.
Target sample size	120

Research contact person
Name of lead principal investigator	Toshiyuki Mori
Organization	Kyorin University, School of medicine
Division name	Department of Surgery
Address	6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL	+81-422-47-5511
Email	mori@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Hirokazu Momose
Organization	Kyorin University, School of medicine
Division name	Department of Surgery
Address	6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL	+81-422-47-5511
Homepage URL
Email	h-momose@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University, School of medicine
Institute
Department

Funding Source
Organization	OLYMPUS corporation
Organization
Division
Category of Funding Organization	Other
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 05 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 12 Day
Anticipated trial start date	2016 Year 05 Month 16 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 05 Month 20 Day
Last modified on	2018 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025706