Venous SystemNCT05519787
A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports
An observational study of Venous System and Venous Access, run by Perouse Medical at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous System, Venous Access, Chemotherapy
- What is being tested?
- Central Veinous access devices' insertion
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2021to 19 May 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: The study population was defined in the protocol as all patients who did receive POLYSITE® or SEESITE® device between 1st October 2016 and 31 December 2017. Any patient who has disagreed with the collection of their personal data would be excluded from this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Venous System, Venous Access, Chemotherapy, Antibiotics, Antiviral, Parenteral Nutrition
- Being tested
- Central Veinous access devices' insertion
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Veinous access devices' insertionDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of veins selected
insertion's location of the POLYSITE®/SEESITE® implantable port
Measured: 30 days
rate of peri-operative complication
number of complications between the implantation of the device and the first use (as example infections related to manipulation)
Measured: Peri-operative procedure
Secondary outcomes (4)
type of treatments administered
chemotherapy, antibiotics, parenteral nutrition, other
Measured: 5 years
Rate of procedural success
correct placement and correct flow both confirmed by a radiological exam or an echography or an ECG.
Measured: Peri-operative procedure
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
Measured: 30 Days
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.
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 start14 Dec 2021
- Primary completion19 May 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous SystemStudies 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
- 70 participants (actual)
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
- NCT05519787
- Sponsor's protocol ID
- PSSS-2021-MONO
- 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, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports
- ClinicalTrials.gov ID
- NCT05519787
- Acronym / sponsor ID
- PSSS-2021-MONO
- Conditions
- Venous System, Venous Access, Chemotherapy, Antibiotics, Antiviral, Parenteral Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Perouse MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Eclevar Medtech
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population was defined in the protocol as all patients who did receive POLYSITE® or SEESITE® device between 1st October 2016 and 31 December 2017. Any patient who has disagreed with the collection of their personal data would be excluded from this study.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Central Veinous access devices' insertionMedical 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. | Device | – |
Primary outcome
Identification of veins selected
Time frame: 30 days
insertion's location of the POLYSITE®/SEESITE® implantable port
rate of peri-operative complication
Time frame: Peri-operative procedure
number of complications between the implantation of the device and the first use (as example infections related to manipulation)
4 secondary outcomes
type of treatments administered
Time frame: 5 years
Rate of procedural success
Time frame: Peri-operative procedure
short-term complication
Time frame: 30 Days
rate of long-term complications
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous System and Venous Access, run by Perouse Medical at 1 site 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 3 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: finished, 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of veins selected (time frame: 30 days). The study lists 2 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; AzTrials last refreshed its copy on 31 Oct 2026.