Patients in Need for Intravenous AccessNCT02197013
Evaluation of Introcan Safety 3 Closed IV Catheter
An observational study of Patients in Need for Intravenous Access, run by B. Braun Melsungen AG at 1 site in Germany.
Trial summary
Incidence and time of occurrence of blood leakage with the closed intravascular catheter Introcan Safety 3 in comparison to Introcan Safety Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients in Need for Intravenous Access
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Oct 2012
- 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: Patients in need for intravenous access
Who may be able to join
- need for intravenous access
Who cannot join
- n. a.
Trial locations and contacts
1 site in 1 country.
About this study
Incidence and time of occurrence of blood leakage with the closed intravascular catheter Introcan Safety 3 in comparison to Introcan Safety
- Conditions
- Patients in Need for Intravenous Access
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 |
|---|---|---|
| Introcan Safety 3 | Closed IV Catheter | |
| Introcan Safety | IV catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and time of occurence of blood leakage
Measured: Within one minute
Secondary outcomes (2)
Problems during catheter insertion and fixation of Introcan Safety 3
Measured: During insertion and fixation of catheter
Necessity of disconnection of catheter
Measured: During catheter placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients in Need for Intravenous AccessStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gertrud Haeseler, Prof., Principal investigator, KKRN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197013
- Sponsor's protocol ID
- HC-O-H-1207
- Status last verified
- Aug 2023
- First submitted
- 17 Jul 2014
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Introcan Safety 3 Closed IV Catheter
- ClinicalTrials.gov ID
- NCT02197013
- Acronym / sponsor ID
- HC-O-H-1207
- Conditions
- Patients in Need for Intravenous Access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Jul 2014 (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.
Incidence and time of occurrence of blood leakage with the closed intravascular catheter Introcan Safety 3 in comparison to Introcan Safety
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Introcan Safety 3 | – | –Closed IV Catheter |
| Introcan Safety | – | –IV catheter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in need for intravenous access
Key inclusion criteria (1 listed)
- need for intravenous access
Key exclusion criteria (1 listed)
- n. a.
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
Frequency and time of occurence of blood leakage
Time frame: Within one minute
2 secondary outcomes
Problems during catheter insertion and fixation of Introcan Safety 3
Time frame: During insertion and fixation of catheter
Necessity of disconnection of catheter
Time frame: During catheter placement
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 3 Aug 2023.
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.
Gertrud Haeseler, Prof. principal investigator
KKRN
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 Patients in Need for Intravenous Access, run by B. Braun Melsungen AG at 1 site in Germany.
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: finished, as of the sponsor's last update on 3 Aug 2023. 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 Germany. 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?
Frequency and time of occurence of blood leakage (time frame: Within one minute). 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 3 Aug 2023.