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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034763
Receipt No. R000039644
Scientific Title A study evaluating the efficacy and safety of cold polypectomy for large Sessile serrated adenoma/polyps (10 mm or larger)
Date of disclosure of the study information 2018/11/04
Last modified on 2020/11/07

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Basic information
Public title A study evaluating the efficacy and safety of cold polypectomy for large Sessile serrated adenoma/polyps (10 mm or larger)
Acronym A study evaluating the efficacy of cold polypectomy for large SSA/P (10 mm or larger)
Scientific Title A study evaluating the efficacy and safety of cold polypectomy for large Sessile serrated adenoma/polyps (10 mm or larger)
Scientific Title:Acronym A study evaluating the efficacy of cold polypectomy for large SSA/P (10 mm or larger)
Region
Japan

Condition
Condition Sessile serrated adenoma/polyps(SSA/P)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of cold polypectomy for large SSA/P (10 mm or larger)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The presence of residual serrated neoplasia in biopsy specimens
Key secondary outcomes The rate of adverse events, Procedure time, Diagnostic predictive value

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with 10mm or more SSA/P
Key exclusion criteria 1. Inflammatory bowel diseases
2. Hb < 9 g/dl
3. PT-INR > = 3
4. Pregnant women
5. Patients with severe heart/kidney/liver diseases
6. Patients in disagreement with informed consent
7. Others
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Kimoto
Middle name
Last name Yoshiaki
Organization NTT Medical Center Tokyo
Division name Department of Gastroenterology
Zip code 141-8625
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL 03-3448-6111
Email kimoto.yoshiaki@icloud.com

Public contact
Name of contact person
1st name Kimoto
Middle name
Last name Yoshiaki
Organization NTT Medical Center Tokyo
Division name Department of Gastroenterology
Zip code 141-8625
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL 03-3448-6111
Homepage URL
Email kimoto.yoshiaki@icloud.com

Sponsor
Institute NTT Medical Center Tokyo
Institute
Department

Funding Source
Organization NTT Medical Center Tokyo
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NTT Medical Center Tokyo
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
Tel 03-3448-6111
Email kimoto.yoshiaki@icloud.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 NTT東日本関東病院

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 04 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 300
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 11 Month 04 Day
Date of IRB
2018 Year 11 Month 13 Day
Anticipated trial start date
2018 Year 11 Month 13 Day
Last follow-up date
2024 Year 11 Month 12 Day
Date of closure to data entry
2024 Year 11 Month 12 Day
Date trial data considered complete
2024 Year 11 Month 12 Day
Date analysis concluded
2024 Year 11 Month 12 Day

Other
Other related information none

Management information
Registered date
2018 Year 11 Month 04 Day
Last modified on
2020 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039644

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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