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Clinical Trials/NCT00600444
NCT00600444
Completed
Not Applicable

Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

Heidelberg University1 site in 1 country100 target enrollmentFebruary 2008
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Heidelberg University
Enrollment
100
Locations
1
Primary Endpoint
Primary success rate of the randomized intervention
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
May 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Age equal or greater than 18 years
  • Patients scheduled for primary elective implantation of TIAP

Exclusion Criteria

  • Participation in another clinical trial which could interfere with the primary endpoint of this study
  • Lack of compliance
  • Impaired mental state or language problem
  • Patients with known allergy to contrast agent

Outcomes

Primary Outcomes

Primary success rate of the randomized intervention

Time Frame: Assessed on the day of surgery (day 0)

Secondary Outcomes

  • Peri-/postoperative complication rate for the randomized intervention(Assessed after 90 day post operation)

Study Sites (1)

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