Clinical trial · Interventional
Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy
A Prospective Randomized Study of the Vortex® Implantable Access Port Versus the BardPort™ Implantable Port in Cancer Patients Receiving Adjuvant Intravenous Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Giving chemotherapy drugs through an implanted port reduces the need for multiple needle sticks. It is not yet known whether one type of port is more effective than another in reducing infections and other side effects associated with long-term port use. PURPOSE: This randomized clinical trial is comparing two types of ports in patients with cancer receiving intravenous chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
| Vascular Access Device Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vascular access device placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Port
- description
- Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
- interventionNames
- Procedure: vascular access device placement
- type
- EXPERIMENTAL
- label
- Vortex Implantable Access Port
- description
- Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
- interventionNames
- Procedure: vascular access device placement
Primary outcomes (1)
- measure
- Port Failure Within 12 Months of Port Insertion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of malignancy requiring intravenous chemotherapy for ≥ 6 months * Must undergo entire course of chemotherapy at the Mayo Clinic in Jacksonville, unless the outside treating institution agrees to submit the research data sheet to Mayo Clinic * Scheduled time frame for regular use of the vascular access port ≥ 3 months after port insertion PATIENT CHARACTERISTICS: * Life expectancy ≥ 6 months * No active skin condition implicating an elevated risk of local or systemic infectious or non-infectious complications, including any of the following: * Current skin infection * Cutaneous lymphoma * Auto-immune disorders * Active vasculitis * Connective tissue diseases * No known active infection requiring antibiotic therapy at the time of port implantation * Patients without an active infection who are on chronic antibiotic suppressive therapy are eligible * No concurrent illness requiring chronic anticoagulation * Patients who develop other comorbidities requiring chronic anticoagulation during the study period are eligible PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available