Viewing Study NCT03512899



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Last Modification Date: 2024-10-26 @ 12:45 PM
Study NCT ID: NCT03512899
Status: COMPLETED
Last Update Posted: 2023-07-25
First Post: 2018-02-06

Brief Title: Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports
Sponsor: AC Camargo Cancer Center
Organization: AC Camargo Cancer Center

Study Overview

Official Title: Internal Jugular Vein Versus Axillary Vein With Single-incision for Implantable Ports a Prospective and Randomized Study
Status: COMPLETED
Status Verified Date: 2021-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Comparison between internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients Investigators are recruiting 240 patients and randomizing 120 for each arm Primary outcome is early complications until 30 days and secondary outcome late complications between 30 days and 6 months The follow-up is 12 months
Detailed Description: Prospective and randomized trial comparing internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients Investigators are recruiting 240 patients and randomizing 120 for each arm in a single center study at AC Camargo Cancer Center Every surgery is assisted by ultrasound and radioscopic and the catheter is districath 85 French Clinical assessment will be at 10 days and every 3 months after surgery Primary outcome is early complications until 30 days and secondary outcome late complications between 30 days and 6 months The follow-up is 12 months

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None