UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053750 |
|---|---|
| Receipt number | R000061339 |
| Scientific Title | Evaluation of the impact of high-frequency therapy equipment on cardiac implantable devices during endoscopic therapy |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/09/02 09:40:48 |
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Basic information
Public title
Evaluation of the impact of endoscopic treatment on pacemakers
Acronym
Evaluation of the impact of endoscopic treatment on pacemakers
Scientific Title
Evaluation of the impact of high-frequency therapy equipment on cardiac implantable devices during endoscopic therapy
Scientific Title:Acronym
ESD-CIEDs study
Region
| Japan |
Condition
Condition
digestive diseases
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the impact of high-frequency therapy equipment on pacemakers during endoscopic therapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intracardial electrocardiogram
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
| 18 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with cardiac implantable devices
Key exclusion criteria
Lead disconnection and suspected patient
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | EIJI |
| Middle name | |
| Last name | UZA |
Organization
Osaka International Cancer Institute
Division name
Anesthesiology Clinical Engineering office
Zip code
541-8567
Address
3-1-69 Otemae,Chuo-ku,Osaka
TEL
06-6945-1181
eiji.uza@oici.jp
Public contact
Name of contact person
| 1st name | EIJI |
| Middle name | |
| Last name | UZA |
Organization
Osaka International Cancer Institute
Division name
Anesthesiology Clinical Engineering office
Zip code
541-8567
Address
3-1-69 Otemae,Chuo-ku,Osaka
TEL
06-6945-1181
Homepage URL
eiji.uza@oici.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
none
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
Osaka International Cancer Institute IRB
Address
3-1-69 Otemae,Chuo-ku,Osaka
Tel
0669451181
eiji.uza@oici.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 | 04 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
HYOGO MEDICAL UNIVERSITY HOSPITAL
Nara Medical University Hospita
Management information
Registered date
| 2024 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061339
