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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033294
Receipt No. R000037660
Scientific Title A pilot study of SI-449 adhesion barrier system in patients who are scheduled to undergo temporary ileostomy.
Date of disclosure of the study information 2018/07/22
Last modified on 2019/07/16

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Basic information
Public title A pilot study of SI-449 adhesion barrier system in patients who are scheduled to undergo temporary ileostomy.
Acronym A pilot study of SI-449 adhesion barrier system
Scientific Title A pilot study of SI-449 adhesion barrier system in patients who are scheduled to undergo temporary ileostomy.
Scientific Title:Acronym A pilot study of SI-449 adhesion barrier system
Region
Japan

Condition
Condition Patients with rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The study objectives are to assess the safety and manageability of SI-449 adhesion barrier system in patients who are planned to undergo temporary ileostomy. In addition, efficacy is evaluated exploratively.
Basic objectives2 Others
Basic objectives -Others Safety, manageability and efficacy
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse events, Laboratory tests and manageability
Key secondary outcomes The incidence of adhesions after surgery

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 SI-449
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 Key inclusion criteria,
1.Patients who have given their written informed consent to participation in the clinical study based on voluntary agreement after a thorough explanation of subject participation is provided to them.
2.Patients who are planned to have resectomy followed by closure of a temporary ileosotomy as a part of two-stage procedure.
Key exclusion criteria Key exclusion criteria,
1.Patients with history of surgery in the abdominal or pelvic cavity.
2.Patients with having active infection in the abdominal or pelvic cavity.
3.Patients with having active or previous history of peritonitis.
4.Patients with history of hypersensitivity to the investigational device.
5.Patients with a serious hepatic or a serious renal disorder
6.Patients who participated in another clinical study of any drug or medical device within 16 weeks prior to the day of informed consent
7.Any circumstances or conditions, which, in the opinion of the principal investigator or sub-investigator, may affect participation in the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Watanabe
Organization Kitasato University Kitasato Institute Hospital
Division name Surgery
Zip code 108-8642
Address 5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL 03-3444-6161
Email si449mwatanabe@gmail.com

Public contact
Name of contact person
1st name Clinical project team
Middle name
Last name SI-449
Organization Seikagaku corporation
Division name Clinical development dept
Zip code 100-0005
Address 6-1, Marunouchi 1, Chiyoda-ku, Tokyo 100-0005, Japan.
TEL 03-5220-8593
Homepage URL
Email si_449_1021@seikagaku.co.jp

Sponsor
Institute Seikagaku corporation
Institute
Department

Funding Source
Organization Seikagaku 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 Asahi General Hospital Institutional Review Board
Address 1326, I, Asahi-shi, Chiba, 289-2500, Japan
Tel 0479-63-8111
Email si449asahi@gmail.com

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
2018 Year 07 Month 22 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 No longer recruiting
Date of protocol fixation
2018 Year 04 Month 18 Day
Date of IRB
2018 Year 06 Month 07 Day
Anticipated trial start date
2018 Year 07 Month 23 Day
Last follow-up date
2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 05 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037660

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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