VeinousNCT05519761
A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports
An observational study of Veinous and Chemotherapy, run by Perouse Medical at 3 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Veinous, Chemotherapy, Antibiotics
- What is being tested?
- Implantation of veinous access ports
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 250 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Mar 2022to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
CHR d'Orléans
Orléans, 45100
Adel Abou Mrad, MD
- Recruiting
Hopital Foch
Suresnes, 92150
Alexandre Valée, MD
- Recruiting
IGR
Villejuif, 94805
Frédéric Gomas, MD
About this study
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.
- Conditions
- Veinous, Chemotherapy, Antibiotics, Antiviral Drugs, Parenteral Nutrition, Blood Transfusion
- Being tested
- Implantation of veinous access ports
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of veinous access portsDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance : success of the insertion and placement of the implantable port.
evaluation of the success of the insertion and placement of the implantable port.
Measured: 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
Measured: Peri-procedure
Associate Performance : correct device insertion assess Clinical endpoint
percentage of patients with correct placement objectively assessed by clinical observation
Measured: Peri-procedure
Per-procedure Safety
evaluation of the safety of the implantable ports
Measured: 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.
Measured: 30 days
Secondary outcomes (7)
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
Measured: 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…).
Measured: 5 years
Safety: perioperative time
duration between the implantation procedure and the first use of the implantable port
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Emergent Risks
AEs collection
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start15 Mar 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VeinousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perouse Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eclevar Medtech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519761
- Sponsor's protocol ID
- PSSS-2021-MULTI
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports
- ClinicalTrials.gov ID
- NCT05519761
- Acronym / sponsor ID
- PSSS-2021-MULTI
- Conditions
- Veinous, Chemotherapy, Antibiotics, Antiviral Drugs, Parenteral Nutrition, Blood Transfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Perouse MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Eclevar Medtech
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of veinous access portsThe 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. | Device | – |
Primary outcome
Performance : success of the insertion and placement of the implantable port.
Time frame: Peri-procedure
evaluation of the success of the insertion and placement of the implantable port.
Associate Performance : correct device insertion assess by Radiological endpoint
Time frame: Peri-procedure
percentage of patients with correct insertion into venous access objectively assessed via radiography, ECG or echography measurement
Associate Performance : correct device insertion assess Clinical endpoint
Time frame: Peri-procedure
percentage of patients with correct placement objectively assessed by clinical observation
Per-procedure Safety
Time frame: 30 Days
evaluation of the safety of the implantable ports
Associated Safety : rate of complications
Time frame: 30 days
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.
7 secondary outcomes
Performance : evaluation of the device performance
Time frame: 5 years
device failure
Time frame: 5 years
Safety: perioperative time
Time frame: 5 years
Safety FU period: Device Failure Removal
Time frame: 5 years
Safety Long Term period: Device Failure Removal
Time frame: 5 years
Safety Long Term period: complications
Time frame: 5 years
Emergent Risks
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Veinous and Chemotherapy, run by Perouse Medical at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chems Hachani, CEO (33 699150368, chachani@eclevar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance : success of the insertion and placement of the implantable port. (time frame: Peri-procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.