UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003547
Receipt number R000004303
Scientific Title Development of endoscopic submucosal dissection using new endoscopic device (Hood Clipper)
Date of disclosure of the study information 2010/05/01
Last modified on 2010/04/27 03:14:00

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Basic information

Public title

Development of endoscopic submucosal dissection using new endoscopic device (Hood Clipper)

Acronym

New endoscopic device (Hood Clipper) for endoscopic submucosal dissection

Scientific Title

Development of endoscopic submucosal dissection using new endoscopic device (Hood Clipper)

Scientific Title:Acronym

New endoscopic device (Hood Clipper) for endoscopic submucosal dissection

Region

Japan


Condition

Condition

early gastric,esopahgeal and rectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Development of new device to improve the efficacy and safety of endoscopic submucosal dissection

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary endpoint of this study is to evaluate the operation time of submucosal dissection using new device.

Key secondary outcomes

1) enbloc resection rate
2) safety


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

Endoscopic submucosal dissection

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Depth of invasion was limited to the mucosa or thin layer of submucosa (evaluated by endoscopy and /or endoscopic ultrasonography).
(2) N0M0 eavluated by CT scan (if submucosal invasion was suspected).
(3) Performance status(ECOG) is 0 or 1.
(4) fulfill all the criteria indicated below (within 30 days before treatment, ULN: upper limit of the institution).
i) white blood cell count
no fewer than 3000/mm3
no more than 10000/mm3
ii) hemoglobin
more than 9.0 g/dl(No blood transfusion was done within 14 days before treatment).
iii) platelet count
more than 100,000/mm3
iv) GOT
less or equal ULN X2.5
v) GPT
less or equal ULN X2.5
vi) T-Bil
less or equal 3.0mg/ml
vi) serum creatinine
less or equal 2.0mg/ml
(5) Written informed consent is essential.

Key exclusion criteria

(1) Cases with the component of poorly differetiated carcinoma in the biopsy specimen.
(2) Cases with active multiple cancers.
(3) Cases with severe complication.(i.e., decompensated liver cirrhosis, severe ischemic heart disease and renal failure, poorly-controlled diabetes mellitus, chronic respiratory failure requiring for continuous oxygen administration, Discontinuation of anticoagulant therapy can not be allowed).
(4) Woman in pregnancy (or woman of child bearing potential) and breast-feeding woman.
(5) Cases with uncontrolled psychiatric disease.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin'ichi Miyamoto

Organization

Kyoto University

Division name

Department of Gatroenterology and Hepatology

Zip code


Address

54 Shogoin Kawaharachou Sakyo-ku, Kyoto, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kyoto University

Division name

Department of Gatroenterology and Hepatology

Zip code


Address


TEL


Homepage URL


Email

shmiyamo@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

FUJIFILM 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


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

2010 Year 05 Month 01 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

2006 Year 02 Month 23 Day

Date of IRB


Anticipated trial start date

2006 Year 03 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

2010 Year 04 Month 27 Day

Last modified on

2010 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004303


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name