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Comparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy

NCT03410121 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2025-08-05

No results posted yet for this study

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

  • Solid Tumor, Adult
  • Chemotherapy Treatment
  • Advanced or Metastasis Stage

Interventions

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

Sponsors & Collaborators

  • Center Eugene Marquis

    lead OTHER

Principal Investigators

  • Laurence CROUZET, MD · Centre Eugène Marquis, Rennes, France

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-09
Primary Completion
2023-12-26
Completion
2024-09-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03410121 on ClinicalTrials.gov