UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053384 |
|---|---|
| Receipt number | R000060930 |
| Scientific Title | Evaluation of the usefulness and safety of a novel traction clip in endoscopic submucosal dissection (ESD). |
| Date of disclosure of the study information | 2024/01/18 |
| Last modified on | 2024/01/18 12:42:39 |
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Basic information
Public title
Evaluation of the Utility and Safety of a Novel Multipoint Traction Clip in Endoscopic Submucosal Dissection (ESD)
Acronym
Verification of the usefulness and safety of multi-point traction clips
Scientific Title
Evaluation of the usefulness and safety of a novel traction clip in endoscopic submucosal dissection (ESD).
Scientific Title:Acronym
Verification of usefulness and safety of new traction clips
Region
| Japan |
Condition
Condition
gastrointestinal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic submucosal dissection (ESD) is a widely used treatment for gastrointestinal cancer. In recent years, the use of traction devices instead of clips has emerged as a treatment technique, reducing the difficulty of the procedure. However, existing traction devices can only provide traction at a single point, and their traction effect may be insufficient for large lesions. In this study, we developed a new traction device using orthodontic rubber and medical sutures, and will examine its usefulness and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to apply new instruments and completion rate
Key secondary outcomes
Treatment time, batch resection rate, amount of local fluid used, and frequency of incidentalities (treatment-related bleeding, post-treatment hemorrhage, perforation)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who will be eligible for insurance coverage of endoscopic submucosal dissection between March 1 and December 31, 2022, and who have been fully informed about their participation in the study, and who have given their free and voluntary consent to be treated with the new device based on their full understanding of the study.
Key exclusion criteria
Exclusion criteria include suspected disseminated intravascular coagulation syndrome, severe heart failure, active thromboembolism at the time of study entry, severe respiratory failure, pregnancy or women of childbearing potential, and other subjects deemed unsuitable by the study investigator (subinvestigator).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Okamura |
Organization
Nagasaki Harbor Medical Center
Division name
gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
TEL
0958223251
taku.okamu1002@gmail.com
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Okamura |
Organization
Nagasaki Harbor Medical Center
Division name
gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
TEL
0958223251
Homepage URL
taku.okamu1002@gmail.com
Sponsor or person
Institute
Nagasaki Harbor Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagasaki Minato Medical Center Research and Development Center
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
Tel
0958223251
kenkyu@ncho.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
| 2024 | Year | 01 | 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
20
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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We have developed a new traction device made of orthodontic rubber and medical sutures, and will examine its usefulness and safety. The new traction device is characterized by its ability to provide traction at three points, unlike conventional traction devices. Phantom experiments have confirmed that the new traction device has more traction force than the conventional device, which makes the treatment procedure easier. The main objective of this study was to evaluate the safety and efficacy of ESD using the new traction device in real clinical practice. The key clinical outcomes will be evaluated: time to apply and complete use of the novel device, treatment time, en bloc resection rate, local fluid use, and frequency of complications (treatment-related bleeding, posterior hemorrhage, and perforation).
Eligible patients will be those for whom endoscopic submucosal dissection will be covered by insurance between March 1 and December 31, 2022, and who, after receiving a full explanation of their participation in the study and with full understanding, have given their free and voluntary consent to be treated using the new device. The above information will be obtained based on the electronic medical record.
Management information
Registered date
| 2024 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060930
