UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010356 |
|---|---|
| Receipt number | 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 09:12:51 |
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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
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
Kazuo_Tamada@terumo.co.jp
Sponsor or person
Institute
Terumo Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012120
