A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports

Chemotherapy Clinical Trial

Official title:

A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05519787
• Other study ID #: PSSS-2021-MONO
• Status: Completed
• Start date: December 14, 2021
• Est. completion date: May 19, 2022

Study information

• Verified date: August 2022
• Source: Perouse Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a retrospective, observational, monocenter case series. The purpose of this study is to collect clinical data to describe the use of POLYSITE® and SEESITE® devices and verify overall safety and performance. This study is part of the Post-Market Clinical Follow-up (PMCF) activities of the PEROUSE MEDICAL manufacturer. The primary data source for this study was patient's medical records from a French Hospital. The study population was defined as all patients who did receive POLYSITE® and SEESITE®. Data from a minimum of 50 patients were planned for the statistical review.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adult and pediatric population
• Patient who received the implantation of any POLYSITE® or SEESITE® implantable port referenced in the Annex 1 of the current protocol between 1st October 2016 and 31st December 2017

Exclusion Criteria:

• Patient who refused the data collection according to RGPD regulation applicable in France
• Patient who received the implantation of another device than those presented in Annex 1 of the current protocol.
• Patient who received the implantation of a POLYSITE® or SEESITE® implantable port after 31st December 2017

Related Conditions & MeSH terms

• Antibiotics
• Chemotherapy
• Parenteral Nutrition
• Venous Access

Intervention

Device:
• Central Veinous access devices' insertion
Medical doctor should complete a questionnaire with medical history or any important clinical data that could help for the selection of the location of the port and catheter placement. The insertion will be planned only by a surgeon, interventional radiologist, or anaesthesiologist in the surgery block. For the patient with a medical history of PICC line, PAC implantation, Central venous access device of any kind, or clinical risk of veinous compression (cervical or subclavian adenopathy, pelerine syndrome, mediastinal involvement…). An echo Doppler exam of the veinous cervical system is required before surgery. This exam should identify potential thrombosis that required a special treatment. It is important that the surgeon who will perform the device's insertion is aware of any history or risks of veinous thrombosis, stenosis, or phlebitis for the patient to avoid procedure's failure.

Locations

Country	Name	City	State
France	CHR d'Orléans	Orléans

Sponsors (2)

Lead Sponsor	Collaborator
Perouse Medical	ECLEVAR MEDTECH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of veins selected	insertion's location of the POLYSITE®/SEESITE® implantable port	30 days
Primary	rate of peri-operative complication	number of complications between the implantation of the device and the first use (as example infections related to manipulation)	Peri-operative procedure
Secondary	type of treatments administered	chemotherapy, antibiotics, parenteral nutrition, other	5 years
Secondary	Rate of procedural success	correct placement and correct flow both confirmed by a radiological exam or an echography or an ECG.	Peri-operative procedure
Secondary	short-term complication	number of complications: infections, bleeding and hematoma, pneumothorax, hemothorax and pleural effusion, pain, and mechanical dysfunction (catheter fracture, occlusion, and port-pocket dehiscence, pinch-off, embolization, leak, port/catheter disconnection	30 Days
Secondary	rate of long-term complications	number of complications after 30 days of the implantation surgery up to the end of the follow-up: infections, inflammation, skin disorders, catheter-related venous thrombosis, mechanical dysfunction as occlusion/rupture/fracture/disconnection of the catheter, drug extravasation, mal-position, flip-over, migration, pinch-off.	5 years