CClinicalTrials.gg
Status unknownNCT03547921Updated Jun 6, 2018

Primary Upper Limb Deep Vein Thrombosis. Is First Rib Resection Necessary?

An observational study in Paget Schroetter Syndrome, sponsored by Sheba Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by Sheba Medical Center · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to compare outcome of patients with effort thrombosis who were treated operatively to those treated nonoperatively

02

Conditions studied

03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's planned enrollment of 20 is below the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients who were previously treated for upper extremity DVT ( anticoagulation- with or without 1st rib resection)

Eligibility criteria

Inclusion Criteria:\

* patients treated for upper extremity DVT

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • operative

    operative

    Device: iu22 ultrasound system - phillips

  • non operative

    non operative

    Device: iu22 ultrasound system - phillips

Interventions

  • Deviceiu22 ultrasound system - phillips

    iu22 ultrasound system - phillips

06

What researchers measure

Primary outcomes

  1. clinical differences

    clinical differences between the 2 groups Patients will be evaluated by the " Villata" post thrombotic syndrome (PTS) scoring system. The sum of each parameter will be used to compare he groups Vilata PTS scoring system: ( 0- ABSENT , 3 SEVERE ) Symptoms/clinical signs None Mild Moderate Severe Symptoms Pain Cramps Heaviness Pruritus Clinical signs edema Skin induration Hyperpigmentation Redness Venous ectasia Pain on calf compression

    Time frame: 10years

Secondary outcomes

  1. vein patency

    patency of SCV based on duplex

    Time frame: 10 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03547921
Lead sponsor
Sheba Medical Center
Responsible party
Dr. Daniel Silverberg (vascular surgeon, Sheba Medical Center) — Principal investigator
First posted
Jun 6, 2018
Start date
Jul 1, 2018 (estimated)
Primary completion
Jul 1, 2018 (estimated)
Completion
Sep 1, 2018 (estimated)
Last update
Jun 6, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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