Feasibility of Transnasal ECHO for Identification of Para... | NCT03838640

Studies
Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery

NCT03838640

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

May 10, 2022Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

To Assess Feasibility of the New Application

Interventions

EPIQ 5

Countries

Israel

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

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2019Actual

Primary Completion Date

May 1, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Dec 24, 2018

First Submission Date that Met QC Criteria

Feb 11, 2019

First Posted Date

Feb 12, 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

May 6, 2022

Last Update Posted Date

May 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Identification and preservation of internal carotid artery during endoscopic nasopharyngectomy in cases of malignancy is a main difficulty of this kind of surgery, especially when anatomy is distorted by previous radiation. Intraoperative navigation based on preoperative imaging cannot remain precise throughout the process of resection. We aim to check a feasibility of internal carotid artery localization with the help of transnasal ultrasonic scanning. The most appropriate for this method existing device is an echocardiography system with pediatric transesophageal transducer.

We plan to use it in 20 patients undergoing elective surgery for inflammatory sino-nasal disease. After initiatioin of general anesthesia and local decongestion, transducer will be placed transnasally to nasopharynx in order to scan a parapharyngeal space.

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Consecutive eligible patients requiring endoscopic surgery for sinonasal pathology Transnasal localization of internal carotid artery with TEE ECHO device will be performed	Device: EPIQ 5

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EPIQ 5	Device	As described in summary Trade name of the device Philips EPIQ 5	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
distance from nasopharynx surface to a closest wall of internal carotid arter	cm	3 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication for endoscopic nose and paranasal sinuses surgery

Exclusion Criteria:

Previous nasopharyngeal surgery

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky		52621	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

No plans to share

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided