An observational study in Veinous, Chemotherapy and Antibiotics, sponsored by Perouse Medical. Status unknown at 3 sites in France. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by Perouse Medical · Observational
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.
Perouse Medical is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All references of POLYSITE® and SEESITE® implantable ports apply to adult targeted population group.
Only POLYSITE® and SEESITE® implantable ports referenced as 2000 series (micro size) and connected to a 5F catheter apply to paediatric (>10 kg) targeted population groups.
Exclusion Criteria:
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.
Performance : success of the insertion and placement of the implantable port.
evaluation of the success of the insertion and placement of the implantable port.
Time frame: Peri-procedure
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
Time frame: Peri-procedure
Associate Performance : correct device insertion assess Clinical endpoint
percentage of patients with correct placement objectively assessed by clinical observation
Time frame: Peri-procedure
Per-procedure Safety
evaluation of the safety of the implantable ports
Time frame: 30 Days
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.
Time frame: 30 days
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
Time frame: 5 years
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...).
Time frame: 5 years
Safety: perioperative time
duration between the implantation procedure and the first use of the implantable port
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years
Emergent Risks
AEs collection
Time frame: 5 years
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Perouse Medical