A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports

Chemotherapy Clinical Trial

Official title:

A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519761
• Other study ID #: PSSS-2021-MULTI
• Status: Recruiting
• Start date: March 15, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: August 2022
• Source: Perouse Medical
• Contact: Chems Hachani, CEO
• Phone: 33 699150368
• Email: chachani[@]eclevar.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate performance and safety of POLYSITE® and SEESITE® implantable ports allowing repeated and prolonged access to the venous system for the administration of chemotherapy, antibiotics, antiviral drugs, parenteral nutrition, and for blood transfusion or blood derivatives transfusion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adult and paediatric population
• Patient who received the implantation of any POLYSITE® or SEESITE® implantable port referenced in the Annex 1 of the current protocol between 1-JAN-2018 and 31-DEC-2020

Exclusion Criteria:

• Patient who refused the data collection according to GDPR regulation applicable in France
• Patient who received the implantation of another device than those presented in Annex 1 of the current protocol.

Related Conditions & MeSH terms

• Antibiotics
• Blood Transfusion
• Chemotherapy
• Parenteral Nutrition

Intervention

Device:
• Implantation of veinous access ports
The surgeon, anaesthetist and interventional radiologist should be thoroughly familiar with the surgical procedure, instruments, and device characteristics prior to performing the implantation. The nurse has also to be familiar with the implantable port since he/she intervenes in it at the time of the Huber needle puncture and solution injection.

Locations

Country	Name	City	State
France	CHR d'Orléans	Orléans
France	Hopital Foch	Suresnes
France	IGR	Villejuif

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	Performance : success of the insertion and placement of the implantable port.	evaluation of the success of the insertion and placement of the implantable port.	Peri-procedure
Primary	Associate Performance : correct device insertion assess by Radiological endpoint	percentage of patients with correct insertion into venous access objectively assessed via radiography, ECG or echography measurement	Peri-procedure
Primary	Associate Performance : correct device insertion assess Clinical endpoint	percentage of patients with correct placement objectively assessed by clinical observation	Peri-procedure
Primary	Per-procedure Safety	evaluation of the safety of the implantable ports	30 Days
Primary	Associated Safety : rate of complications	measurement of the rate of complications reported during the short-term period of 30 days after the implantation date. As example, the following short-term complications will be looked at: infections, bleeding and hematoma, pneumothorax, hemothorax and pleural effusion, pain.	30 days
Secondary	Performance : evaluation of the device performance	percentage of patients with correct device insertion by the general surgeon, anaesthetist, or the radiologist. The insertion could be done under Echo or under fluoroscopy or ECG	5 years
Secondary	device failure	measurement of the rate of device failure throughout the study until the device is removed from the patient's body. The device failures are defined as mechanical dysfunctions (catheter fracture, occlusion, and port-pocket dehiscence, pinch-off, embolization, leak, port/catheter disconnection, drug extravasation, mal-position, flip-over, migration, local venous thrombosis, etc…).	5 years
Secondary	Safety: perioperative time	duration between the implantation procedure and the first use of the implantable port	5 years
Secondary	Safety FU period: Device Failure Removal	the complications will be followed up to 30 days after the implantable port removal. If the removal is related to a device failure or a complication related to the device, the patient's safety will be followed until the resolution of the complication.the complications will be followed up to 30 days after the implantable port removal. If the removal is related to a device failure or a complication related to the device, the patient's safety will be followed until the resolution of the complication.	5 years
Secondary	Safety Long Term period: Device Failure Removal	the complications will be followed up to 30 days after the implantable duration starting after the first 30 days after the implantation procedure and up to device removal, or patient death, or lost to follow-up, depending on what event comes first in the patient's medical chart. Study timepoints have been defined as 6-months Follow-up after the Implantation procedure, 12-months Follow-up after the Implantation procedure, 24-months Followup after the Implantation procedure and 36-months Follow-up after the Implantation procedure.	5 years
Secondary	Safety Long Term period: complications	measurement of the rate of complications reported during the whole study and at the defined study timepoints. As example, the following long-term complications will be looked at: infections, inflammation, skin disorders, catheter-related venous thrombosis, pinch-off.	5 years
Secondary	Emergent Risks	AEs collection	5 years