UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057267 |
|---|---|
| Receipt number | R000065459 |
| Scientific Title | Safety and efficacy of biopsy technique using over the scope clip in high-risk patients for gastrointestinal endoscopic biopsy: a single-center, single-arm, open-label, interventional study |
| Date of disclosure of the study information | 2025/03/15 |
| Last modified on | 2025/03/12 13:56:43 |
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Basic information
Public title
Safety and efficacy of biopsy technique using over the scope clip in high-risk patients for gastrointestinal endoscopic biopsy: a single-center, single-arm, open-label, interventional study
Acronym
Safety and efficacy of biopsy technique using over the scope clip in high-risk patients for gastrointestinal endoscopic biopsy
Scientific Title
Safety and efficacy of biopsy technique using over the scope clip in high-risk patients for gastrointestinal endoscopic biopsy: a single-center, single-arm, open-label, interventional study
Scientific Title:Acronym
Safety and efficacy of biopsy technique using over the scope clip in high-risk patients for gastrointestinal endoscopic biopsy
Region
| Japan |
Condition
Condition
Gastrointestinal biopsy high-risk cases
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of biopsy techniques using over the scope clip in high-risk patients for gastrointestinal endoscopic biopsy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of total perforations (intraoperative and delayed perforations)
Key secondary outcomes
Intraoperative perforation rate
Rate of delayed perforation
Intraoperative complications
Intraoperative death rate
Examination time
Macroscopic specimen size
Macroscopic specimen findings
Findings of tissue specimens
Whether tissue evaluation is acceptable for biopsy purposes
Ratio of postoperative complications
Ratio of postoperative complications
Time or days of fluid intake postoperatively
Time or number of days of food intake after surgery
Length of hospital stay
Abdominal symptons
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Perform a endoscopic biopsy with prophylactic use of an over the scope clip (OTSC).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients at risk for gastrointestinal biopsy (chronic pseudo intestinal obstruction, giant colon disease, inflammatory bowel disease, patients with colonic diverticulum disease, etc.)
(2) Patients who are at least 18 years old at the time of consent
(3) Gender: Any
Key exclusion criteria
(1) Patients for whom it is difficult to perform endoscopy
(2) Patients who cannot obtain consent
(3) Patients with serious renal, hepatic, or cardiac disease
(4) Patients who are participating in other clinical studies. (4) Patients who are participating in other clinical research, except for observational research.
(5) Other patients whom the principal investigator or subinvestigator determines to be inappropriate to conduct this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Takaomi |
Organization
International university of health and welfare Narita hospital
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476355600
takaomi0027@gmail.com
Public contact
Name of contact person
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International university health and welfare Narita hospitall
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476355600
Homepage URL
takaomi0027@gmail.com
Sponsor or person
Institute
International university of health and welfare Narita hospital
Institute
Department
Personal name
Funding Source
Organization
Self
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
International university health and welfare Narita hospital
Address
852, Hatakeda, Narita, Chiba
Tel
0476355600
takaomi0027@gmail.com
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
| 2025 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 12 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065459
