Clinical trial · Interventional
Power Injectable Versus a Non-Power Injectable, Upper Arm, TIVAD for Chemotherapy
Assessment of a Power Injectable vs. a Non-Power Injectable, Upper Arm, Totally Implanted Venous Access Devices for 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)
Patients with cancer often require intravenous chemotherapy for long periods of time. Ensuring that these patients have safe and reliable access to the veins for chemotherapy is challenging, and sometimes a medical device is required to administer the chemotherapy into the veins. A totally implanted venous access device, or port, is implanted under the skin of the arm and is attached to a small plastic catheter that enters into the veins. This device can be punctured with a needle when needed for treatment or testing. Some types of these vein ports can rapidly inject fluids (power injection), and can be used for follow-up imaging studies, such as computed tomography, that are required to follow cancer treatment effectiveness. There are no publications of randomized patients discussing the impact of power injection upon TIVAD complications and device longevity for arm implantation. The investigators propose to compare the effectiveness of power injectable against non-power injectable ports to determine if they have different clinical performance and complications. Our results will impact the care provided to cancer patients.
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 |
|---|---|---|---|
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Power Injectable Port (Cook Vital Mini Port) | Device | — | UNRESOLVED |
| Power Injectable Port (AngioDynamics Smart Port CT Mini) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Power Injectable Port
- description
- The subjects randomized to this group will receive the newer, power injectable port.
- interventionNames
- Device: Power Injectable Port (AngioDynamics Smart Port CT Mini)
- type
- ACTIVE_COMPARATOR
- label
- Non-Power Injectable Port
- description
- The subjects randomized to this group will receive the older, non-power injectable port.
- interventionNames
- Device: Non-Power Injectable Port (Cook Vital Mini Port)
Primary outcomes (1)
- measure
- Device Failure (Failure secondary to occlusion, leakage, catheter fracture, wound dehiscence)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Consecutive patients breast cancer requiring intravenous chemotherapy, referred from our local Cancer Agency for arm TIVAD, will be included. Exclusion Criteria: * • Those under the age of 16 years; * Those with uncorrectable blood clotting disorder; * Pregnant women, as they will not be candidates for chemotherapy; * Any person with an active infection or immunocompromised state; * Those on oral or intravenous antibiotics on the day of TIVAD implantation.
References
Publications (3)
- BACKGROUNDGoossens GA, Stas M, Jerome M, Moons P. Systematic review: malfunction of totally implantable venous access devices in cancer patients. Support Care Cancer. 2011 Jul;19(7):883-98. doi: 10.1007/s00520-011-1171-3. Epub 2011 May 10. PMID 21556721
- BACKGROUNDMarcy PY, Chamorey E, Amoretti N, Benezery K, Bensadoun RJ, Bozec A, Poissonnet G, Dassonville O, Rame M, Italiano A, Peyrade F, Brenac F, Gallard JC. A comparison between distal and proximal port device insertion in head and neck cancer. Eur J Surg Oncol. 2008 Nov;34(11):1262-9. doi: 10.1016/j.ejso.2007.09.011. Epub 2007 Nov 5. PMID 17981432
- BACKGROUNDGoltz JP, Machann W, Noack C, Hahn D, Kickuth R. Feasibility of power contrast injections and bolus triggering during CT scans in oncologic patients with totally implantable venous access ports of the forearm. Acta Radiol. 2011 Feb 1;52(1):41-7. doi: 10.1258/ar.2010.100238. PMID 21498324