UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010879 |
|---|---|
| Receipt number | R000012729 |
| Scientific Title | Phase I/II study for Cold polypectomy |
| Date of disclosure of the study information | 2013/06/10 |
| Last modified on | 2017/12/08 09:18:34 |
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Basic information
Public title
Phase I/II study for Cold polypectomy
Acronym
Cold polypectomy PI/II
Scientific Title
Phase I/II study for Cold polypectomy
Scientific Title:Acronym
Cold polypectomy PI/II
Region
| Japan |
Condition
Condition
Colorectal polyp <10mm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of cold polypectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
PI: Incidence of tumor residue in the additional resection.
PII: Cumulative delayed bleeding rate
Key secondary outcomes
PI: Incidence of spurting bleeding just after cold polypectomy. Incidence of intra-operative bleeding after EMR. R0 resection rate in cold polypectomy. adverse events.
PII: Incidence of immediate bleeding. Hemostasis during colonoscopy. R0 resection rate. adverse events. Procedure time.
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
| Maneuver |
Interventions/Control_1
Cold polypectomy
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
1) 20 y.o. <
2) Patients undergoing colorectal polypectomy
(polyps < 10mm)
3) Written Informed consent.
Key exclusion criteria
1) Polyps > 10mm
2) Patients with advanced cancer or hemorrhoid.
3) Patients with IBD, polyposis, known colon cancer.
4) Patients with anticoagulant or antiplatelet therapy. Patients with bleeding tendency.
5) Important organ failure.
6) Patient without informed consent.
7) others
Target sample size
310
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoji Takeuchi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Gastrointestinal Oncology
Zip code
Address
1-3-3 Nakamichi Higashinari-ku Osaka
TEL
06-6972-1181
takeuti-yo@mc.preosaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikako Matsumoto |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Institutional Review Board
Zip code
Address
1-3-3 Nakamichi Higashinari-ku Osaka
TEL
06-6972-1181
Homepage URL
matsumotochi@opho.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases, Gastrointestinal Oncology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 05 | Day |
Last modified on
| 2017 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012729
