UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028069
Receipt number R000029097
Scientific Title Tactile sensing system for laparoscopic surgery
Date of disclosure of the study information 2017/07/15
Last modified on 2018/07/18 17:49:43

* 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

Tactile sensing system for laparoscopic surgery

Acronym

Tactile sensing system for laparoscopic surgery

Scientific Title

Tactile sensing system for laparoscopic surgery

Scientific Title:Acronym

Tactile sensing system for laparoscopic surgery

Region

Japan


Condition

Condition

Gastric Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Ehe effectiveness of tactile sensing system for laparoscopic surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The detection rate of early gastric cancer lesion or marked clip

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

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

operation

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) Histologically proven gastric adenocarcinoma.
2) cStage IA(T1N0) or IB(T1N1, T2[MP]N0) or IIA(T3[SS]N0).
3) PS(ECOG) of 0 or 1.
4) No history of upper abdominal surgery.

Key exclusion criteria

1) Infectious disease with systemic therapy indicated.
2) Body temperature of 38 or more degrees Celsius.
3) Women during pregnancy or breast-feeding.
4) Severe mental disease.
5) Continuous systemic steroid therapy.
6) Unstable angina pectoris, or history of myocardial infarction within six months.
7) Uncontrollable hypertension.
8) Uncontrollable diabetes millutus.
9) Severe respiratory disease requiring continuous oxygen therapy.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michitaka FUJIWARA

Organization

Nagoya University Graduate School of Medicine

Division name

Clinical Simulation Center

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

TEL

052-744-2238

Email

mfuji@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chie TANAKA

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

TEL

052-744-2245

Homepage URL


Email

chtanaka@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

2017 Year 07 Month 15 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

Open public recruiting

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 01 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

2017 Year 07 Month 04 Day

Last modified on

2018 Year 07 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029097


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name