SynovitisNCT00903903
Computer-Assisted Quantification of the Synovial Perfusion in Patients With Arthritis Using Two-Dimensional and Three-Dimensional Power Doppler Ultrasonography
An observational study of Synovitis, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to compare the data obtained by computer-aided quantification of the synovial perfusion in patients with arthritis using two-dimensional and three-dimensional power Doppler ultrasonography and the clinical data used to represent the degree of joint inflammation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Synovitis
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2009to Mar 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Arthritis patients who visited the Rheumatology out patient clinic in Taichung Veterans General Hospital
Who may be able to join
- patients with at least one painful swollen peripheral joint observed by a rheumatologist, including:
- shoulder joints
- elbow joints
- wrist joints
- metacarpophalangeal (MCP) AND
- proximal interphalangeal (PIP) joints of hands, ankle joints, subtalar joints, mid-tarsal joints, MTP and PIP joints of feet
Who cannot join
- patients with active infection
- patients with concurrent malignant disease
- patients with a history of traumatic, septic, or cystal arthritis
- previous joint surgery, or isotopic synovectomy within the past 12 months before the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Hsin-Hua Chen, M.D., 886-4-23592525 ext. 3336, shc5555@hotmail.com
About this study
The purpose of this study is to compare the data obtained by computer-aided quantification of the synovial perfusion in patients with arthritis using two-dimensional and three-dimensional power Doppler ultrasonography and the clinical data used to represent the degree of joint inflammation. Intra- and inter-observer reliability of this method will also be determined.
- Conditions
- Synovitis
- Keywords
- active synovitis
- Medical subject headings
- Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | RA patients with at least one active synovitis | |
| 2 | Non-RA patients with at least one active synovitis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SynovitisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903903
- Sponsor's protocol ID
- IRB TCVGH No:C09048
- Status last verified
- May 2009
- First submitted
- 15 May 2009
- Last updated
- 19 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Quantification of the Synovial Perfusion in Patients With Arthritis Using Two-Dimensional and Three-Dimensional Power Doppler Ultrasonography
- ClinicalTrials.gov ID
- NCT00903903
- Acronym / sponsor ID
- IRB TCVGH No:C09048
- Conditions
- Synovitis
- Keywords
- active synovitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 19 May 2009 (estimated)
- 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 this study is to compare the data obtained by computer-aided quantification of the synovial perfusion in patients with arthritis using two-dimensional and three-dimensional power Doppler ultrasonography and the clinical data used to represent the degree of joint inflammation. Intra- and inter-observer reliability of this method will also be determined.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –RA patients with at least one active synovitis |
| 2 | – | –Non-RA patients with at least one active synovitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Arthritis patients who visited the Rheumatology out patient clinic in Taichung Veterans General Hospital
Key inclusion criteria (6 listed)
- patients with at least one painful swollen peripheral joint observed by a rheumatologist, including:
Key exclusion criteria (4 listed)
- patients with active infection
- patients with concurrent malignant disease
- patients with a history of traumatic, septic, or cystal arthritis
- previous joint surgery, or isotopic synovectomy within the past 12 months before the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Synovitis, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 6 inclusion and 4 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 19 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Hsin-Hua Chen, M.D. (886-4-23592525 ext. 3336, shc5555@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 May 2009.