NCT01000909

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

First QC Date

October 22, 2009

Last Update Submit

June 28, 2010

Conditions

Interventions

increased venous pressure is predictive for chronic venous insufficiency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Part I:
  • Clinical signs of venous disease, former deep vein thrombosis (DVT)
  • Part II:
  • Former deep vein thrombosis, former vein surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zurich, Switzerland

RECRUITING

MeSH Terms

Interventions

High-Energy Shock WavesVenous Pressure

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaBlood PressureHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Central Study Contacts

01 Studienregister MasterAdmins

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 23, 2009

Study Start

July 1, 2009

Study Completion

July 1, 2010

Last Updated

June 29, 2010

Record last verified: 2010-06

Locations