UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033294 |
|---|---|
| Receipt number | 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 | 2023/11/17 13:38:42 |
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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
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
reply@seikagaku.co.jp
Sponsor or person
Institute
Seikagaku corporation
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037660
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
