UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044736 |
|---|---|
| Receipt number | R000051093 |
| Scientific Title | An Improvised T-Fastener for Gastropexy during Radiologically Inserted Gastrostomy |
| Date of disclosure of the study information | 2021/08/06 |
| Last modified on | 2021/07/02 01:36:15 |
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Basic information
Public title
An Improvised T-Fastener for
Gastropexy during Radiologically
Inserted Gastrostomy
Acronym
An Improvised T-Fastener for
Gastropexy during Radiologically
Inserted Gastrostomy
Scientific Title
An Improvised T-Fastener for
Gastropexy during Radiologically
Inserted Gastrostomy
Scientific Title:Acronym
An Improvised T-Fastener for
Gastropexy during Radiologically
Inserted Gastrostomy
Region
| Asia(except Japan) |
Condition
Condition
Need for feeding gastrostomy
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the safety and effectiveness of an improvised T-fastener for gastropexy during radiological insertion of a gastrostomy tube.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
Success of the procedure
Key secondary outcomes
Incidence of complications;
Ease of use when compared with commercial T-Fastener.
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
| Device,equipment |
Interventions/Control_1
Improvised T-fastener/GI anchoring suture
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients presenting for a Radiologically Inserted Gastrostomy
Key exclusion criteria
Failure to give consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Omar Abbas |
| Middle name | Ahmed |
| Last name | Malik |
Organization
Jinnah Postgraduate Medical Center
Division name
Radiology
Zip code
75510
Address
Rafiqui Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh
TEL
00922199201300
tariqradiologist@gmail.com
Public contact
Name of contact person
| 1st name | Omar Abbas |
| Middle name | Ahmed |
| Last name | Malik |
Organization
Jinnah Postgraduate Medical Center
Division name
Radiology
Zip code
75510
Address
Cyberknife, JPMC, Rafiqui Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh
TEL
00923362363569
Homepage URL
omar.a.a.malik@gmail.com
Sponsor or person
Institute
Jinnah Postgraduate Medical Center;
Radiology
Institute
Department
Personal name
Funding Source
Organization
None/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
IRB, Jinnah Postgraduate Medical Center
Address
JPMC, Rafiqui Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh
Tel
00923008239781
tarqradiologist@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
Jinnah Postgraduate Medical Center, Karachi, Pakistan
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
| 2021 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 02 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051093
