NCT05519761

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

August 26, 2022

Last Update Submit

August 26, 2022

Conditions

VeinousChemotherapyAntibioticsAntiviral DrugsParenteral NutritionBlood TransfusionBlood Derivatives TransfusionPMCF Study

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • Associate Performance : correct device insertion assess Clinical endpoint

    percentage of patients with correct placement objectively assessed by clinical observation

    Peri-procedure

  • Per-procedure Safety

    evaluation of the safety of the implantable ports

    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.

    30 days

Secondary Outcomes (7)

  • Performance : evaluation of the device performance

    5 years

  • device failure

    5 years

  • Safety: perioperative time

    5 years

  • Safety FU period: Device Failure Removal

    5 years

  • Safety Long Term period: Device Failure Removal

    5 years

  • +2 more secondary outcomes

Interventions

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.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHR d'Orléans

Orléans, 45100, France

RECRUITING

Hopital Foch

Suresnes, 92150, France

RECRUITING

IGR

Villejuif, 94805, France

RECRUITING

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Chems Hachani, CEO

CONTACT

33 699150368chachani@eclevar.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 29, 2022

Study Start

March 15, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

August 29, 2022

Record last verified: 2022-08

Locations

FR(3)