Paget Schroetter SyndromeNCT03547921
Primary Upper Limb Deep Vein Thrombosis. Is First Rib Resection Necessary?
An observational study of Paget Schroetter Syndrome, run by Sheba Medical Center.
Trial summary
The purpose of the study is to compare outcome of patients with effort thrombosis who were treated operatively to those treated nonoperatively Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paget Schroetter Syndrome
- What is being tested?
- iu22 ultrasound system - phillips
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who were previously treated for upper extremity DVT ( anticoagulation- with or without 1st rib resection)
Who may be able to join
- patients treated for upper extremity DVT
Who cannot join
- none
About this study
The purpose of the study is to compare outcome of patients with effort thrombosis who were treated operatively to those treated nonoperatively
- Conditions
- Paget Schroetter Syndrome
- Being tested
- iu22 ultrasound system - phillips
- Medical subject headings
- Upper Extremity Deep Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iu22 ultrasound system - phillipsDevice
iu22 ultrasound system - phillips
| Study group | Role | What they receive |
|---|---|---|
| operative | operative Receives: Device: iu22 ultrasound system - phillips | |
| non operative | non operative Receives: Device: iu22 ultrasound system - phillips |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10years
Secondary outcomes (1)
vein patency
patency of SCV based on duplex
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paget Schroetter SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Daniel Silverberg, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547921
- Sponsor's protocol ID
- sheba-18-4765-DS-CTIL
- Status last verified
- May 2018
- First submitted
- 28 Mar 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Upper Limb Deep Vein Thrombosis. Is First Rib Resection Necessary?
- ClinicalTrials.gov ID
- NCT03547921
- Acronym / sponsor ID
- sheba-18-4765-DS-CTIL
- Conditions
- Paget Schroetter Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare outcome of patients with effort thrombosis who were treated operatively to those treated nonoperatively
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| operative | – | Device: iu22 ultrasound system - phillipsoperative |
| non operative | – | Device: iu22 ultrasound system - phillipsnon operative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who were previously treated for upper extremity DVT ( anticoagulation- with or without 1st rib resection)
Key inclusion criteria (1 listed)
- patients treated for upper extremity DVT
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iu22 ultrasound system - phillipsiu22 ultrasound system - phillips | Device | non operative, operative |
Primary outcome
clinical differences
Time frame: 10years
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
1 secondary outcome
vein patency
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Paget Schroetter Syndrome, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical differences (time frame: 10years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.