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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03838640
Other study ID # 5450-18-SMC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 5, 2019
Est. completion date May 1, 2022

Study information

Verified date May 2022
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Indication for endoscopic nose and paranasal sinuses surgery Exclusion Criteria: Previous nasopharyngeal surgery

Study Design


Related Conditions & MeSH terms

  • To Assess Feasibility of the New Application

Intervention

Device:
EPIQ 5
As described in summary Trade name of the device Philips EPIQ 5

Locations

Country Name City State
Israel Sheba Medical Center Tel Hashomer

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary distance from nasopharynx surface to a closest wall of internal carotid arter cm 3 minutes