An interventional study of IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108. and Vital Port®Minititanium in Solid Tumor, Adult, Chemotherapy Treatment and Advanced or Metastasis Stage, sponsored by Center Eugene Marquis. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Center Eugene Marquis · Not applicable, Interventional, and Other
The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. They will be randomized either in the thoracic implantation, either in the humeral implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm and 429 into the thoracic one. Number of complications related to the implantable device, medico-economic analysis as well as patient satisfaction will be assessed.
Every patients with solid tumor requiring medical device implantation for intravenous chemotherapy treatment will be eligible.
Both humeral and thoracic implantation of medical device are standard procedures. The randomization in a specific arm is the study procedure and is considered as an interventional study in France.
Exclusion Criteria:
The intervention is characterized by the randomization into thoracic arm which means that patients will have an implantable Venous Access Device implanted into thoracic location
Device: IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.
The intervention is characterized by the randomization into humeral arm which means that patients will have an implantable Venous Access Device implanted into humeral location
Device: Vital Port®Minititanium
Implantation of intravenous medical device in thoracic location
Implantation of intravenous medical device in humeral location
Number of complications related to Implantable Venous Access Device
Number of complications that will be recorded by medical oncologist
Time frame: 3 months after medical device placement
Plan to share: No
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Center Eugene Marquis