Clinical trial · Interventional
Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
Evaluation of the Safety and Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter for Peripheral Intravenous (PIV) Insertion in Children, Oncology Patients and Elderly: a Controlled Randomized Trial
NCT00914069CI-TRIAL-00026977terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding Stopped
Summary
Brief summary (as posted)
The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vascular Access Complication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional vascular access | Device | — | UNRESOLVED |
| RIVS vascular access | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RIVS vascular access
- description
- RIVS vascular access
- interventionNames
- Device: RIVS vascular access
- type
- ACTIVE_COMPARATOR
- label
- Conventional vascular access
- description
- Conventional vascular access
- interventionNames
- Device: Conventional vascular access
Primary outcomes (2)
- measure
- IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt
- timeFrame
- An access attempt usually ranges from 0 to 45 minutes in duration.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria * Any type of oncology patients undergoing chemotherapy or post-chemotherapy (without a port/cannula), or over 65 years * Requires peripheral IV as determined by examining physician * Requires the IV when a study nurse or resident is available * Able to sign an informed consent Exclusion Criteria * Active systemic or cutaneous infection or inflammation; * Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; * Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline International Normalized Ratio (INR) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); * Currently involved in any other investigational clinical trials; * Previous vascular grafts or surgery at the target vessel access site; * Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; * Central line available * Requirement for immediate IV placement (patient's condition would potentially be compromised if there is a time delay in IV placement)
References
Publications (0)
Data not yet available
No reference posted for this study.