UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046410 |
|---|---|
| Receipt number | R000052954 |
| Scientific Title | Prospective feasibility study on the efficacy and safety of the novel spiral dilator for EUS-guided drainage |
| Date of disclosure of the study information | 2021/12/18 |
| Last modified on | 2022/07/14 09:00:40 |
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Basic information
Public title
Prospective feasibility study on the efficacy and safety of the novel spiral dilator for EUS-guided drainage
Acronym
Prospective feasibility study on the efficacy and safety of the novel spiral dilator for EUS-guided drainage
Scientific Title
Prospective feasibility study on the efficacy and safety of the novel spiral dilator for EUS-guided drainage
Scientific Title:Acronym
Prospective feasibility study on the efficacy and safety of the novel spiral dilator for EUS-guided drainage
Region
| Japan |
Condition
Condition
biliary obstruction, cholecystitis, pancreatic duct obstruction, abcess
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of novel spiral dilator (Tornus ES) for EUS-guided drainage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
technical success rate
Key secondary outcomes
success rate of dilation using Tornus ES
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
EUS-guided drainage
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 who undergo EUS-guided drainage
obtaining written informed consent
Key exclusion criteria
bleeding tendency
poor general condition
massive ascites around the pancture site
pregnancy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Ogawa |
Organization
Sendai City Medical Center
Division name
Department of gastroenterology
Zip code
983-0824
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL
0222521111
t-ogawa@openhp.or.jp
Public contact
Name of contact person
| 1st name | Takahisa |
| Middle name | |
| Last name | Ogawa |
Organization
Sendai City Medical Center
Division name
Department of gastroenterology
Zip code
983-0824
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL
0222521111
Homepage URL
t-ogawa@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
nothing
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
the institutional review board of Sendai City Medical Center
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
Tel
022-252-1111
k.tochikubo@openhp.or.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
| 2021 | Year | 12 | Month | 18 | 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
10
Results
The technical success rate and the success rate of dilation using a Tornus ES were both 100%. The mean procedure time was 27 minutes. No adverse events related to the procedure occurred in all cases.
Results date posted
| 2022 | Year | 07 | Month | 14 | Day |
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
| 2021 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 18 | Day |
Last modified on
| 2022 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052954
