UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017575 |
|---|---|
| Receipt number | R000020235 |
| Scientific Title | A pilot prospective study on the safety and efficacy of the DN-D2718B knife for endoscopic submucosal dissection. |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2017/11/16 14:35:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A pilot prospective study on the safety and efficacy of the DN-D2718B knife for endoscopic submucosal dissection.
Acronym
The safety and efficacy of the DN-D2718B knife for endoscopic submucosal dissection.
Scientific Title
A pilot prospective study on the safety and efficacy of the DN-D2718B knife for endoscopic submucosal dissection.
Scientific Title:Acronym
The safety and efficacy of the DN-D2718B knife for endoscopic submucosal dissection.
Region
| Japan |
Condition
Condition
Early malignant neoplasms of the esophagogastrointestinal tract
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to evaluate the safety and efficacy of the DN-D2718B knife during endoscopic submucosal dissection (ESD) through a prospective trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Intraoperative adverse events
-Time required for ESD
-Whether another ESD knife is required for completion of ESD
-Postoperative adverse events including postoperative bleeding and delayed perforation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
All cases due to undergo ESD will be included in this study.
Key exclusion criteria
No exclusion criteria
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Fujishiro |
Organization
The University of Tokyo Hospital
Division name
Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL
+81-3-38155411
mtfujish-kkr@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sakaguchi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology, Graduate School of Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL
+81-3-38155411
Homepage URL
sakaguchi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
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
| 2015 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/DOI/DOI?10.1055/s-0043-111720
Number of participants that the trial has enrolled
Results
ESD with this novel knife is feasible even when performed by non-experts
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
| 2015 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A random sample prospective single-arm observatory trial
Management information
Registered date
| 2015 | Year | 05 | Month | 14 | Day |
Last modified on
| 2017 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020235
