is Ultrasound-guided Foam Sclerotherapy a Cost-effective... | NCT04655417

Studies
is Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?

NCT04655417

Sponsor

Combined Military Hospital, Pakistan

Status

Unknown status

Last Update Posted

Dec 7, 2020Actual

Enrollment

70Estimated

Phase

Early Phase 1

Conditions

Pain
Leg Edema
Cost Effectiveness
Cosmesis

Interventions

Sodium Tetradecyl Sulfate

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2020Actual

Primary Completion Date

Feb 21, 2021Estimated

Completion Date

Feb 21, 2021Estimated

First Submitted Date

Nov 13, 2020

First Submission Date that Met QC Criteria

Nov 30, 2020

First Posted Date

Dec 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2020

Last Update Posted Date

Dec 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Anum Arif, Dr Anum Arif, Combined Military Hospital, PakistanPrincipal Investigator

Lead Sponsor

Combined Military Hospital, PakistanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

. It is the aim of this paper is to discuss our experience of foam sclerotherapy for varicose veins atour hospital

Detailed Description

we will manage all patients with vericose veins with injection sclerotherapy and will monitor there response in terms of relive in vsisble veins, swelling and pain.

we also want to evaluate hoe many sessions of injection sclerotherapy are required for complete resolution of symptoms.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INTERVENTION GROUP	Experimental	SINGLE ARM OF PATIENTS WHO WILL RECEIVE SAME TREATMENT	Drug: Sodium Tetradecyl Sulfate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium Tetradecyl Sulfate	Drug	DRUG WILL BE INJECTED TO ALLAPTIENTS ACCORDING TO STANDARD PROTOCOL	INTERVENTION GROUP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain by VAS score	pain by VAS score	1 MONTH
leg edema	leg edema	1 MONTH
cosmesis	cosmesis	1 MONTH
cost effectiveness	cost effectiveness	1 MONTH

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All the patients who present with symptomatic varicose veins underwent a duplex scan by radiologist to identify site of reflux and condition of deep veins. If the patient is a candidate for intervention then he is offered surgery or foam sclerotherapy

Exclusion Criteria:

recurrent and secondary varicose veins

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anum Arif, MBBS FCPS	Contact	+923422398424		dranumarif@yahoo.com
AHSIN BHATTI, MBBS FCPS	Contact	+923422398424		AHSINMB@YAHOO.COM

Overall Officials

Name	Affiliation	Role
Anum Arif	Combined military hospital lahore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anum Arif	Recruiting	Lahore	Select A State Or Province	0092	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012981	Sodium Tetradecyl Sulfate

Ancestor Terms

ID	Term
D005233	Fatty Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000476	Alkanesulfonates

Browse Leaves

Not provided

Browse Branches

Not provided