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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05519761
Other study ID # PSSS-2021-MULTI
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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
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