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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040961
Receipt No. R000046237
Scientific Title Feasibility study investigating the efficacy and safety of endoscopic submucosal dissection (ESD) using a thin-endoscope for superficial pharyngeal neoplasms
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/30

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Basic information
Public title Feasibility study investigating the efficacy and safety of endoscopic submucosal dissection (ESD) using a thin-endoscope for superficial pharyngeal neoplasms
Acronym Efficacy and safety of a thin-endoscope ESD for superficial pharyngeal neoplasms
Scientific Title Feasibility study investigating the efficacy and safety of endoscopic submucosal dissection (ESD) using a thin-endoscope for superficial pharyngeal neoplasms
Scientific Title:Acronym Efficacy and safety of a thin-endoscope ESD for superficial pharyngeal neoplasms
Region
Japan

Condition
Condition superficial pharyngeal neoplasms
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of endoscopic submucosal dissection using a thin-endoscope for superficial pharyngeal neoplasms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Completion rate/R0 resection rate
Key secondary outcomes Procedure time, the rate of adverse events (perforation, delayed-bleeding, etc.)

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 ESD for superficial pharyngeal neoplasms
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 superficial pharyngeal neoplasms
Key exclusion criteria 1.Pharyngeal neoplasms that cannot be expected curative resection by endoscopic treatment
2.Patients in disagreement with informed consent
3.Others
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Muramoto
Organization NTT Medical Center Tokyo
Division name Department of Gastrointestinal Endoscopy
Zip code 141-8625
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL +81-3-3448-6111
Email t.muramoto7711@gmail.com

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Muramoto
Organization NTT Medical Center Tokyo
Division name Department of Gastrointestinal Endoscopy
Zip code 141-8625
Address 5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL +81-3-3448-6111
Homepage URL
Email t.muramoto7711@gmail.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 +81-3-3448-6111
Email t.muramoto7711@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
2020 Year 07 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 Open public recruiting
Date of protocol fixation
2020 Year 05 Month 25 Day
Date of IRB
2020 Year 06 Month 15 Day
Anticipated trial start date
2020 Year 06 Month 15 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 30 Day
Last modified on
2020 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046237

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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