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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010356
Receipt No. R000012120
Scientific Title Multicenter Study of TCD-11091 (Phase III Clinical Study)
Date of disclosure of the study information 2013/04/01
Last modified on 2015/09/29

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Basic information
Public title Multicenter Study of TCD-11091 (Phase III Clinical Study)
Acronym PhaseIII multicenter study of TCD-51073
Scientific Title Multicenter Study of TCD-11091 (Phase III Clinical Study)
Scientific Title:Acronym PhaseIII multicenter study of TCD-51073
Region
Japan

Condition
Condition Patients with primary rectal cancer who are scheduled to undergo loop ileostomy during laparotomy
Classification by specialty
Gastrointestinal surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness and safety of the investigational device (TCD-11091) as an adhesion barrier in patients receiving laparotomy with a colostomy when compared with untreated patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of adhesion under the medial incision at the time of colostomy closure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 TCD-11091(Adhesion Barrier System)
Interventions/Control_2 untreated
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 All patients who must meet the eligibility criteria below will be included in the study. For 1) to 4) and 7), the conditions apply at the time of registration.

1) Patients undergoing a proctectomy with a loop ileostomy under laparotomy (initial surgery), and scheduled to undergo a colostomy closure 3 months to 6 months after ileostomy (second-look surgery)
2) Patients who will undergo initial surgery and second-look surgery under general anesthetics
3) Patients who are indicated for a laparotomy
4) ECOG Performance Status is 0 to 1
5) Patients who are aged at least 20 years on the day of signing the consent form
6) Patients who are able to undergo all scheduled observations and consent to all details of the observations
7) Patients who are able to comply sufficiently with the procedures and specifications in the study
8) Written consent can be obtained from the patients of their own free will in regards to participation in the study, using the consent form approved by the IRB of the individual study institutions.
Key exclusion criteria Patients who meet any of the criteria below at the time of enrolment must be excluded from the study.

1) History of hypersensitivity to substances derived from corn starch
2) Patients who have active cancer other than rectal cancer
3) History of radiotherapy in the abdominal cavity or pelvic cavity
4) History of surgery in the abdominal cavity or pelvic cavity that accompanies a laparotomy scar (excluding surgery for appendicitis)
5) Patients who currently have peritonitis
6) Patients who are subject to emergency surgery
7) Patients who have severe diabetes or disorders of carbohydrate metabolism
8) Patients who have glycogenosis
9) Patients who have a serious hepatic disorder
10) Patients who have a serious renal disorder
11) Patients who are significantly obese (BMI>30)
12) Patients who are required to undergo chronic corticosteroid treatment
13) Patients who are scheduled for another laparotomy in the period between initial surgery and second-look surgery
14) There is a possibility that the laparoscopic assessment of adhesion cannot be conducted safely in the second-look surgery
15) Patients who have participated in other clinical studies within 6 months from the date of signing the consent form, or patients who are currently participating in other clinical studies
16) Patients who are pregnant or lactating
17) Patients who have been tested positive for infections considered by the investigator or subinvestigator as inappropriate for study participation, such as hepatitis B virus, hepatitis C virus, and human immunodeficiency virus
18) Patients who meet medical criteria that hinder the safety or efficacy assessment of the investigational device
19) Patients who have been determined as inappropriate for participation in the study by the investigator or subinvestigator
Target sample size 124

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Watanabe
Organization Kitasato University
Division name Surgery
Zip code
Address 1-15-1 Kitasato,Minami-ku, Sagamihara-shi, Kanagawa, Japa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Terumo Corporation
Division name Clinical Development Department
Zip code
Address
TEL
Homepage URL
Email Kazuo_Tamada@terumo.co.jp

Sponsor
Institute Terumo Corporation
Institute
Department

Funding Source
Organization Terumo 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
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
2013 Year 04 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 10 Month 03 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 06 Day
Last follow-up date
2015 Year 03 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 29 Day
Last modified on
2015 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012120

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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