Blood Vessel ProsthesisNCT00708825
Reverse-Loop Upper Arm Arteriovenous Graft
An observational study of Blood Vessel Prosthesis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: A conventional configured prosthetic arteriovenous graft (AVG) usually wastes most upper arm vessels that a reverse-loop design may conserve. This study examined the feasibility of the AVG construction and its outcome. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Blood Vessel Prosthesis
- How many people
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Dec 2008
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: uremic patient, compromized forarm and elbow options
Who may be able to join
- compromized forearm and elbow options
Who cannot join
- unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reverse-Loop Upper Arm Arteriovenous Graft for Chronic Hemodialysis
Background: A conventional configured prosthetic arteriovenous graft (AVG) usually wastes most upper arm vessels that a reverse-loop design may conserve. This study examined the feasibility of the AVG construction and its outcome.
Methods: Retrospective review of clinical outcomes of reverse-loop upper arm AVG patients. Measures included hemodialysis function, duplex scan, procedural complications, and follow-up interventions
- Conditions
- Blood Vessel Prosthesis
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 | surgical outcome, observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional event-free primary patency
Measured: event-free time
Secondary outcomes (1)
Measures included hemodialysis function, duplex scan, procedural complications, and follow-up interventions.
Measured: events (month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Vessel ProsthesisStudies 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
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Min-Sheng General Hospital
- Investigators
- Chih-Yang Chan, MD, PhD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708825
- Sponsor's protocol ID
- FEMH 97018
- Status last verified
- Jun 2008
- First submitted
- 30 Jun 2008
- Last updated
- 2 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse-Loop Upper Arm Arteriovenous Graft for Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT00708825
- Acronym / sponsor ID
- FEMH 97018
- Conditions
- Blood Vessel Prosthesis
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- Min-Sheng General Hospital
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 2 Jul 2008 (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.
Background: A conventional configured prosthetic arteriovenous graft (AVG) usually wastes most upper arm vessels that a reverse-loop design may conserve. This study examined the feasibility of the AVG construction and its outcome.
Methods: Retrospective review of clinical outcomes of reverse-loop upper arm AVG patients. Measures included hemodialysis function, duplex scan, procedural complications, and follow-up interventions
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –surgical outcome, observation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- uremic patient, compromized forarm and elbow options
Key inclusion criteria (1 listed)
- compromized forearm and elbow options
Key exclusion criteria (1 listed)
- unstable
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
functional event-free primary patency
Time frame: event-free time
1 secondary outcome
Measures included hemodialysis function, duplex scan, procedural complications, and follow-up interventions.
Time frame: events (month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2008.
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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.
Chih-Yang Chan, MD, PhD principal investigator
Far Eastern Memorial Hospital
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 Blood Vessel Prosthesis, run by Far Eastern Memorial 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 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: paused, as of the sponsor's last update on 2 Jul 2008. 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?
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?
functional event-free primary patency (time frame: event-free time). 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 2 Jul 2008.