Trials / Completed
CompletedNCT03410121
Comparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy
Phase IV Study Comparing Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Intravenous Chemotherapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 361 (actual)
- Sponsor
- Center Eugene Marquis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108. | Implantation of intravenous medical device in thoracic location |
| DEVICE | Vital Port®Minititanium | Implantation of intravenous medical device in humeral location |
Timeline
- Start date
- 2018-03-09
- Primary completion
- 2023-12-26
- Completion
- 2024-09-17
- First posted
- 2018-01-25
- Last updated
- 2025-08-05
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03410121. Inclusion in this directory is not an endorsement.