Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541301
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
PICC-ports Versus Chest - Ports for Long Term Chemotherapy Deliverance in Oncology Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PICC-ports Versus Chest - Ports for Long Term Chemotherapy Deliverance in Oncology Patients Affected by Solid Tumors A Prospective Randomized Multicentric Non Inferiority Phase III Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICCHEST
Brief Summary:
Central venous access devices are extensively used in oncology patients The current standard is represented by devices inserted by direct ultrasound guided cannulation of deep veins of suprainfraclavicular area with a reservoir placed in a subcutaneous pocket of the upper chest wall chest-ports More recently PICC Peripherally Inserted Central Catheters-ports have been proposed as an alternative to chest-ports
Aim of this study is to demonstrate the non-inferiority of PICC ports compared to thoracic ports in terms of efficacy and safety
Aim of this study is to demonstrate the non-inferiority of PICC ports compared to thoracic ports in terms of efficacy and safety
Detailed Description:
Central venous access devices are extensively used in oncology patients who need safe deliverance of chemotherapeutic agents and drugs transfusion of blood and blood products and performance of laboratory tests in solid as well as hematologic malignancies These devices are mostly inserted by direct ultrasound guided cannulation of deep veins of suprainfraclavicular area and the reservoir is placed in a subcutaneous pocket of the upper chest wall chest-ports More recently PICC Peripherally Inserted Central Catheters-ports have been proposed as a safe and effective alternative to chest-ports claiming lower invasiveness easier insertion and better patients compliance In PICC-ports a small reservoir is placed in a subcutaneous pocket located in the mid-third of the upper arm
Since these feelings are currently based only on limited retrospective studies aim of this randomized multicenter trial is to demonstrate the non-inferiority of PICC ports experimental arm compared to thoracic ports control arm as the current reference standard in terms of efficacy and safety
Since these feelings are currently based only on limited retrospective studies aim of this randomized multicenter trial is to demonstrate the non-inferiority of PICC ports experimental arm compared to thoracic ports control arm as the current reference standard in terms of efficacy and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None