UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026168
Receipt number R000029965
Scientific Title A prospective study of safety and usefulness of a new miniature wide-field camera for laparoscopic colorectal surgery.
Date of disclosure of the study information 2017/02/21
Last modified on 2019/10/02 11:45:47

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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 or person

Institute

Hiroshima University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029965


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name