- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02197013
Evaluation of Introcan Safety 3 Closed IV Catheter
August 2, 2023 updated by: B. Braun Melsungen AG
Incidence and time of occurrence of blood leakage with the closed intravascular catheter Introcan Safety 3 in comparison to Introcan Safety
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dorsten, Germany
- KKRN Katholisches Klinikum Ruhrgebiet Nord GmbH (KKRN)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients in need for intravenous access
Description
Inclusion Criteria:
- need for intravenous access
Exclusion Criteria:
- n. a.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Introcan Safety 3
Closed IV Catheter
|
Introcan Safety
IV catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency and time of occurence of blood leakage
Time Frame: Within one minute
|
Within one minute
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Problems during catheter insertion and fixation of Introcan Safety 3
Time Frame: During insertion and fixation of catheter
|
During insertion and fixation of catheter
|
Necessity of disconnection of catheter
Time Frame: During catheter placement
|
During catheter placement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gertrud Haeseler, Prof., KKRN
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
July 17, 2014
First Submitted That Met QC Criteria
July 21, 2014
First Posted (Estimated)
July 22, 2014
Study Record Updates
Last Update Posted (Actual)
August 3, 2023
Last Update Submitted That Met QC Criteria
August 2, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- HC-O-H-1207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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