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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000037494 |
Receipt No. | R000042584 |
Scientific Title | The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions-Randomized controlled trial |
Date of disclosure of the study information | 2019/07/25 |
Last modified on | 2020/04/21 |
Basic information | ||
Public title | The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions-Randomized controlled trial | |
Acronym | The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions | |
Scientific Title | The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions-Randomized controlled trial | |
Scientific Title:Acronym | The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions | |
Region |
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Condition | |||
Condition | gastric subepithlial lesion | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The efficacy of endoscopic ultrasound guided fine-needle biopsy using the clip-with-thread method |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Success rate of tissue sampling
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Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Diagnosis | |
Type of intervention |
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Interventions/Control_1 | endoscopic ultrasound guided fine-needle biopsy using the clip-with-thread method | |
Interventions/Control_2 | endoscopic ultrasound guided fine-needle biopsy without the clip-with-thread method | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Patients who are diagnosed SMT and undergo eendoscopic ultrasound guided fine-needle biopsy.
2. Patients from whom written informed consent is obtained. 3. Patients who are older than 20 years old. |
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Key exclusion criteria | 1. Patients who are judged as contraindication for endoscopy.
2. Patients who have metal allergy. 3. Patients who are judged as being inappropriate for this study by their medical doctor. 4. Patients from whom written informed consent is not obtained. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyushu University | ||||||
Division name | Department of Medicine and Bioregulatory Science | ||||||
Zip code | 851-8582 | ||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan | ||||||
TEL | +810926425082 | ||||||
eikichi@intmed3.med.kyushu-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyushu university | ||||||
Division name | Department of Medicine and Bioregulatory Science | ||||||
Zip code | 851-8582 | ||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan | ||||||
TEL | +810926425082 | ||||||
Homepage URL | |||||||
yminoda@med.kyushu-u.ac.jp |
Sponsor | |
Institute | Kyushu University |
Institute | |
Department |
Funding Source | |
Organization | kyushu University |
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 | Kyushu university |
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan |
Tel | +810926425082 |
byskenkyu@jimu.kyushu-u.ac.jp |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042584 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |