Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose

NCT01855425 | Completed Results

• 1 other identifier: 6K0377
• Study Type: interventional
• Target: 96
• Locations: 3 countries
• Sites: 3

Brief Summary

The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.

Conditions

CerebroSpinal Fluid (CSF) Leak; Chronic Otitis Media; Otospongiosis; Otosclerosis; Pulsatile Tinnitus; Cholesteatoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale

  Percentage of Participants with \>=3 Diagnostic Rating Using Radlex Scale. Five radiologists participated in reader study using Radlex scale below to analyze and rate participant images. They determined if they could make a medical diagnosis for ENT patients. Used Radlex Scale - 1-Non-diagnostic, Unacceptable for diagnostic purposes. 2-Limited Acceptable, with some technical defect. 3-Diagnostic, Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary, Good most adequate for diagnostic purposes.

  11 months

Study Arms (1)

Investigational CBCT

OTHER

Radiation

Radiation: Radiation

Interventions

Radiation RADIATION

Subjects to receive standard of care CT scan and additional Cone Beam CT scan.

Investigational CBCT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be 18-80 years of age
• Subjects has provided informed consent
• Subjects must present with symptoms and/or pathology of the sinus or temporal bone region.
• Subject scheduled for additional radiological follow-up and/or endoscopy/surgery.
• CBCT exam performed within a maximum of 2 days of the conventional CT.

You may not qualify if:

• Subjects under the age of 18 years, or over the age of 80 years
• Unable to collect all required case information
• Subjects not willing to consent, or consent is withdrawn
• Women in pregnancy or suspected of being pregnant confirmed by pregnancy test

Sponsors & Collaborators

• Carestream Health, Inc.: lead

Study Sites (3)

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Sint-Augustinus Hospital

Antwerp, Belgium

Location

C.H.U Bicetre

Paris, France

Location

MeSH Terms

Conditions

Otosclerosis; Tinnitus; Cholesteatoma

Interventions

Radiation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

• Title: Susan Pate, RN, MS, RAC
• Organization: Carestream Health, Inc.

susan.pate@carestream.com

585-627-6557

Study Officials

• Douglas Reh, MD

  Johns Hopkins Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Predicate CT Scan and Investigational Cone Beam Scan

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 16, 2013
• Study Start: September 21, 2012
• Primary Completion: August 9, 2013
• Study Completion: August 9, 2013
• Last Updated: August 28, 2018
• Results First Posted: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BE (1); FR (1)