NeoplasmsNCT00386451
Comparing a Closing System Without a Needle With Positive Pressure to a Heparin Lock With Positive Pressure
A study testing Catheter locking systems in people with Neoplasms, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
A prospective randomized study to compare 2 groups: heparine lock with positive pressure lock without a needle with positive pressure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Catheter locking systems
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2006to Jul 2007
- Phase
- Interventional
- 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
Who may be able to join
- Oncological patients who require intravenous chemotherapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Which Compares the Use of a Closing System Without a Needle and With Positive Pressure to a Heparin Lock With Positive Pressure for Patients With a Catheter for Chemotherapy
A prospective randomized study to compare 2 groups:
- heparine lock with positive pressure
- lock without a needle with positive pressure
- Conditions
- Neoplasms
- Being tested
- Catheter locking systems
- Keywords
- Intravenous chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter locking systemsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Caren Randon, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386451
- Sponsor's protocol ID
- 2006/331
- Status last verified
- Apr 2009
- First submitted
- 10 Oct 2006
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Which Compares the Use of a Closing System Without a Needle and With Positive Pressure to a Heparin Lock With Positive Pressure for Patients With a Catheter for Chemotherapy
- ClinicalTrials.gov ID
- NCT00386451
- Acronym / sponsor ID
- 2006/331
- Conditions
- Neoplasms
- Keywords
- Intravenous chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 11 Oct 2006 (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.
A prospective randomized study to compare 2 groups:
- heparine lock with positive pressure
- lock without a needle with positive pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Oncological patients who require intravenous chemotherapy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Catheter locking systems | Device | – |
Primary outcome
Clinical evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2009.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Caren Randon, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter locking systems in people with Neoplasms, run by University Hospital, Ghent at 1 site in Belgium.
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 0 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: finished, as of the sponsor's last update on 27 Apr 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 evaluation. 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 27 Apr 2009.