The Performance / Safety of the Celsite® Venous Access Ports | NCT05572112

Studies
The Performance / Safety of the Celsite® Venous Access Ports

NCT05572112

Sponsor

B.Braun Médical - CoE Chasseneuil

Status

Unknown status

Last Update Posted

Oct 7, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

The Performance / Safety of the Celsite® Venous Access Ports

Interventions

Venous access port implantation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2022Estimated

Primary Completion Date

Jan 30, 2023Estimated

Completion Date

Jan 30, 2025Estimated

First Submitted Date

Oct 5, 2022

First Submission Date that Met QC Criteria

Oct 5, 2022

First Posted Date

Oct 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2022

Last Update Posted Date

Oct 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Celsite® Venous Access Ports System are intended to be used for repeated intravenous administration of, for example, chemotherapy, antibiotic and antiviral drugs, total parenteral nutrition, blood sampling or transfusion.

The objective is to assess the device's safety to deliver medication over the time in regard to the rate of adverse events related to the Celsite® access ports written in the IFU.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Name	Type	Description	Arm Group Labels	Other Names
Venous access port implantation	Device	Venous access port implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the device's safety	The primary variable is the incidence/frequency of all adverse reactions/complications (intraoperative, postoperative, late etc.) which occurred during the study. Focus will be done on all adverse reactions/complications (intraoperative, postoperative, late etc.) related to the Celsite® access ports written in the IFU in comparison with the published data.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is at least 18 years old
Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) prior to all evaluations.
Patient for whom the access port placement has already been determined as the best treatment option within the regular planning of the patient's treatment in accordance with the IFU.
Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol

Exclusion Criteria:

Patient for whom the technical and/ or clinical characteristics of the access port placement or use is outside the scope of the IFU.
Patient not followed-up in the center where the access port is implanted.
Pregnancy
Patient < 18 years of age

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient is at least 18 years old

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided