UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019619 |
|---|---|
| Receipt number | R000022680 |
| Scientific Title | Endoscopic closure of gastrointestinal fistula using polyglycolic acid sheets with fibrin glue |
| Date of disclosure of the study information | 2015/11/04 |
| Last modified on | 2015/11/20 16:43:57 |
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Basic information
Public title
Endoscopic closure of gastrointestinal fistula using polyglycolic acid sheets with fibrin glue
Acronym
Closure of fistula using PGA sheets
Scientific Title
Endoscopic closure of gastrointestinal fistula using polyglycolic acid sheets with fibrin glue
Scientific Title:Acronym
Closure of fistula using PGA sheets
Region
| Japan |
Condition
Condition
Fistula of upper gastrointestinal tract
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Rate of adverse event
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Rate of adverse event
Key secondary outcomes
Rate of closing fistula
Number of the treatment for closing fistula
Curative rate of fistula
Days required curing fistula
Days of admission from initial treatment
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
| Medicine | Maneuver |
Interventions/Control_1
polyglycolic acid (PGA) sheets with fibrin glue
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient diagnosed upper gastrointestinal fistula by esophagogastroduodenoscopy or contrast radiography
2. Patient over 20 years old
3. Patient confirmed by letter of consent
Key exclusion criteria
1. Patient without agreement
2. Patient with pregnancy or breast-feeding
3. Patient with mental illness
4. Patient with severe liver, heart, or renal disease
5. Patient with severe infection
6. Patient with severe bleeding or shock
7. Patient who have allergy for polyglycolic acid (PGA) sheets with fibrin glue
8. Patient who was assessed inadewuancy
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuaki Nagami |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL
06-6645-3811
yasuaki-75@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Nagami |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL
06-6645-3811
Homepage URL
yasuaki-75@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
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
Address
Tel
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
| 2015 | Year | 11 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 04 | Day |
Last modified on
| 2015 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022680
