UMIN-CTR Clinical Trial

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
Email	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
Email	t-ogawa@openhp.or.jp

Sponsor
Institute	Sendai City Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052954