Venous Pressure Measurement of the Great Saphenous Vein U... | NCT01000909

Studies
Venous Pressure Measurement of the Great Saphenous Vein Using Controlled Compression Ultrasound in Healthy Persons and Patients With Chronic Venous Disease as a New Non Invasive Method for Investigation of the Pathophysiology in Primary Varicose Veins

NCT01000909

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Jun 29, 2010Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Chronic Venous Insufficiency

Interventions

Ultrasound (venous pressure measurement)

Countries

Switzerland

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

Status Module

Record Verification Date

Jun 2010

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

Jul 2009

Primary Completion Date

Not provided

Completion Date

Jul 2010

First Submitted Date

Oct 22, 2009

First Submission Date that Met QC Criteria

Oct 22, 2009

First Posted Date

Oct 23, 2009Estimated

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

Jun 28, 2010

Last Update Posted Date

Jun 29, 2010Estimated

Description Module

Brief Summary

Part I:

Proof of concept trial to achieve normal venous pressure values under different provocation maneuvers in healthy persons

Part II:

Non invasive measurement of venous pressure under different provocation maneuvers in patients with chronic venous disease

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound (venous pressure measurement)	Procedure	increased venous pressure is predictive for chronic venous insufficiency

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Part I:

Healthy persons without clinical signs of venous disease, informed consent

Part II:

Patients with chronic venous disease with complete incompetence of the great saphenous vein (Hach IV)
Informed consent

Exclusion criteria:

Part I:

Clinical signs of venous disease, former deep vein thrombosis (DVT)

Part II:

Former deep vein thrombosis, former vein surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic venous disease with complete incompetence of the great saphenous vein

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
01 Studienregister MasterAdmins	Contact	+41 (0)44 255 11 11

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
	Recruiting	Zurich			Switzerland

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves
D014690	Venous Pressure

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation
D055585	Physical Phenomena
D001794	Blood Pressure
D006439	Hemodynamics
D002320	Cardiovascular Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena