UMIN-CTR Clinical Trial

Basic information
Public title	The study of looking for the optimal evaluation method of clinical activity by using new UC-Capsule Endoscopic Sore (UCCAS) LUCCAS study
Acronym	LUCCAS study
Scientific Title	The study of looking for the optimal evaluation method of clinical activity by using new UC-Capsule Endoscopic Sore (UCCAS) LUCCAS study
Scientific Title:Acronym	LUCCAS study
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Utility of colonic capsule endoscopic score (UCCAS) and safety of colonic capsule endoscopic examinaton
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	correlation between UCCAS and CAI
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	colonic capsule endoscopic examination
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	18 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	active UC patients with CAI more than 4 patients with written informed consent patients more than 18 and below 70 years old
Key exclusion criteria	patients with conformed or suspicious intestinal obstruction, stenosis or fistula patients with conformed and suspicious radiation colitis patients who will not be able to perform capsule endoscopy because of the history of abdominal surgery patients treated with operation of pacemaker and/or electric device patients with confirmed and suspicious swallowing disturbance patients with pregnancy and lactation patients with the treatment of malignancy papatients defined inappropriate for the entry into this study
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of gastroenterology and Hepatology
Zip code
Address	1981 Kamoda, Kawagoe City, Saitama, Japan
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1981 Kamoda, Kawagoe City, Saitama, Japan
TEL	049-228-3564
Homepage URL
Email	skato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding 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	2015 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
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	2015 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date	2015 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	2015 Year 01 Month 08 Day
Last modified on	2019 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018755