UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022389
Receipt number R000025706
Scientific Title Intraoperative lens cleaning system for Laparoscope :a prospective randomized controlled study.
Date of disclosure of the study information 2016/05/20
Last modified on 2018/06/25 13:55:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Intraoperative lens cleaning system for Laparoscope :a prospective randomized controlled study.

Acronym

Laparoscopic lens cleaning system (LCS) study.

Scientific Title

Intraoperative lens cleaning system for Laparoscope :a prospective randomized controlled study.

Scientific Title:Acronym

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

1st name
Middle name
Last name Toshiyuki Mori

Organization

Kyorin University, School of medicine

Division name

Department of Surgery

Zip code


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

1st name
Middle name
Last name Hirokazu Momose

Organization

Kyorin University, School of medicine

Division name

Department of Surgery

Zip code


Address

6-20-2 Shinkawa, Mitaka, Tokyo, Japan

TEL

+81-422-47-5511

Homepage URL


Email

h-momose@ks.kyorin-u.ac.jp


Sponsor or person

Institute

Kyorin University, School of medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Terminated

Date of protocol fixation

2016 Year 04 Month 12 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025706


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name