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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name