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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009443
Receipt No. R000010806
Scientific Title Evaluation of intestinal stenosis by Patency Capsule in patients with intestinal obstruction after recovery
Date of disclosure of the study information 2012/12/01
Last modified on 2015/06/08

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Basic information
Public title Evaluation of intestinal stenosis by Patency Capsule in patients with intestinal obstruction after recovery
Acronym Evaluation of intestinal stenosis by Patency Capsule for patients with intestinal obstruction after recovery
Scientific Title Evaluation of intestinal stenosis by Patency Capsule in patients with intestinal obstruction after recovery
Scientific Title:Acronym Evaluation of intestinal stenosis by Patency Capsule for patients with intestinal obstruction after recovery
Region
Japan

Condition
Condition Intestinal obstruction
Classification by specialty
Medicine in general Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the degree of stenosis in patients with intestinal obstruction after recovery by using Patency Capsule, to consider dietary intervention and subsequent recurrence of bowel obstruction
Basic objectives2 Others
Basic objectives -Others Recurrence of intestinal obstruction after the start of feeding

Validity of the results of Patency capsule by intestinal stenosis when surgical treatment was required
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of patency (excretory rate, deformation ratio, emptying time)
Key secondary outcomes Recurrence of recurrent intestinal obstruction after the start of the meal

Validity of the results of Patency capsule by intestinal stenosis when surgical treatment was required

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 Enforcement of a patency capsule
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

Not applicable
Gender Male and Female
Key inclusion criteria Intestinal obstruction has been improved. (passage of stool and flatus were observed).

Passage of the contrast agent can be confirmed by angiography

Able to provide informed consent
Key exclusion criteria 1.Patient with strangulating intestinal obstruction.
2.Patient with complete intestinal obstruction based on contrast study.
3.Patient with colon obstruction
4.Patient with dysphasia
5.Patient with allergy to barium.
6.Patient suspected to have complete intestinal obstruction
7.Patient under 20 years old
8.Serious infectious disease
9.Use or history of peritoneal dialysis
10.Patient who was judged unsuitable by the attending physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyoshi Shibuya
Organization Department of Internal Medicine, Juntendo University
Division name Gastroenterology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email tomoyosi@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyoshi Shibuya
Organization Department of Internal Medicine, Juntendo University
Division name Gastroenterology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email tomoyosi@juntendo.ac.jp

Sponsor
Institute Department of Internal Medicine, Juntendo University
Institute
Department

Funding Source
Organization Department of Internal Medicine,Juntendo University
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
2012 Year 12 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
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2015 Year 06 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 30 Day
Last modified on
2015 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010806

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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