Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard 1 : Thoracic location | Other | 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 |
|
| Standard 2 : Humeral location | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108. | Device | Implantation of intravenous medical device in thoracic location |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of complications related to Implantable Venous Access Device | Number of complications that will be recorded by medical oncologist | 3 months after medical device placement |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laurence CROUZET, MD | Centre Eugène Marquis, Rennes, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center Eugene Marquis | Rennes | Brittany Region | 35000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vital Port®Minititanium | Device | Implantation of intravenous medical device in humeral location |
|