UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026626
Receipt number R000030577
Scientific Title Potential of the anti-fog agent derived from kelp: a pilot study with small-caliber gastroscopy
Date of disclosure of the study information 2017/03/21
Last modified on 2017/03/21 13:12:07

* 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

Potential of the anti-fog agent derived from kelp: a pilot study with small-caliber gastroscopy

Acronym

Potential of the anti-fog agent derived from kelp

Scientific Title

Potential of the anti-fog agent derived from kelp: a pilot study with small-caliber gastroscopy

Scientific Title:Acronym

Potential of the anti-fog agent derived from kelp

Region

Japan


Condition

Condition

patients, who received transoral EGD for their abdominal symptoms, for their annual medical check

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigated the potential of the anti-fog agent derived from kelp

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome was occurrence of examination interruption. Secondary outcomes were total procedure time, the volume of washing solution used during the examination and the cleansing level of the endoscopic lens during the procedure.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

conventional anti-fog agent for gastroscopy

Interventions/Control_2

the anti-fog agent derived from kelp

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

patients who received transoral EGD for their abdominal symptoms, for their annual medical check

Key exclusion criteria

Patients were excluded if they had a history of gastrectomy and allergy for the kelp.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takao Maekita

Organization

Wakayama Medical University

Division name

Department of Gastroenterology

Zip code


Address

811-1 Kimiidera, Wakayama, Wakayama 641-0012, Japan

TEL

073-447-2300

Email

maekita@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takao Maekita

Organization

Wakayama Medical University

Division name

Department of Gastroenterology

Zip code


Address

811-1 Kimiidera, Wakayama, Wakayama 641-0012, Japan

TEL

073-447-2300

Homepage URL


Email

maekita@wakayama-med.ac.jp


Sponsor or person

Institute

Department of Internal Medicine, Nakaya Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Internal Medicine, Nakaya Hospital

Organization

Division

Category of Funding Organization

Self funding

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

裕紫会中谷病院 (和歌山県和歌山市)


Other administrative information

Date of disclosure of the study information

2017 Year 03 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

Open public recruiting

Date of protocol fixation

2014 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2014 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 03 Month 21 Day

Last modified on

2017 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030577


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name