Ultrasound Guided Port-A-Cath Isertion in Cancer Patients | NCT04103021

Studies
Ultrasound Guided Port-A-Cath Isertion in Cancer Patients

NCT04103021

Sponsor

Omar Mokhtar Hussein

Status

Unknown status

Last Update Posted

Sep 25, 2019Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Cancer

Interventions

Port-A-Cath

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

Sep 2019

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 30, 2019Estimated

Primary Completion Date

Oct 30, 2020Estimated

Completion Date

Oct 30, 2020Estimated

First Submitted Date

Sep 22, 2019

First Submission Date that Met QC Criteria

Sep 23, 2019

First Posted Date

Sep 25, 2019Actual

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

Sep 23, 2019

Last Update Posted Date

Sep 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Port-A-Cath is a totally implanted central venous access system and one of the most frequently used systems for administration of chemotherapies in oncological patients .

The currently used techniques for placement of totally implantable venous access devices involve the open insertion by cut down technique, or percutaneous puncture of the central vein either by anatomical landmarks or image guided approach by using ultrasound guidance which is increasingly being preferred over the traditional anatomical landmark due to its low complication rate and high technical success rate; as this technique enables the direct visualization of needle entrance and advancement into the target vein

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Port-a-cath	Experimental	Ultrasound guided Port-a-cath insertion	Device: Port-A-Cath

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Port-A-Cath	Device	Totally implanted central venous access device	Port-a-cath

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early complications	Early complications associated with Ultrasound guided Port-a-cath insertion periprocedural and within 24 hours	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Late complications	complications associated with Ultrasound guided Port-a-cath insertion after 24 hours	Up to 100 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cancer patients
Indicated for receiving long term chemotherapy
Accepted coagulation profile.

Exclusion Criteria:

Severe uncorrectable coagulopathy.
Prior incidence of central vein thrombosis.
Patients with active infection.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19340958	Background	Gebauer B, El-Sheik M, Vogt M, Wagner HJ. Combined ultrasound and fluoroscopy guided port catheter implantation--high success and low complication rate. Eur J Radiol. 2009 Mar;69(3):517-22. doi: 10.1016/j.ejrad.2007.10.018.
25245435	Background	Mudan S, Giakoustidis A, Morrison D, Iosifidou S, Raobaikady R, Neofytou K, Stebbing J. 1000 Port-A-Cath (R) placements by subclavian vein approach: single surgeon experience. World J Surg. 2015 Feb;39(2):328-34. doi: 10.1007/s00268-014-2802-x.

ID	Term
D057785	Catheters
D004864	Equipment and Supplies