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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-21

Study Completion Date

2013-08-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis

NCT05214053

Otosclerosis

TERMINATED NA

Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.

NCT05921578

Otosclerosis Cone Beam Computed Tomography Stapes Fixation

RECRUITING NA

Cone Beam CT Versus Multislice CT in the Postoperative Assessment of Cochlear Implantation

NCT02892552

Cochlear Implants

COMPLETED NA

Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT

NCT05533840

Hearing Loss Tinnitus Vertigo

UNKNOWN

Quantification of Prosthesis Penetration With Conebeam in Otosclerosis

NCT02901093

Otosclerosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. It proposes a direct comparison of diagnostic image quality between the CS 9300 and CT for the ability to view and confirm ENT disorders.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Predicate CT Scan and Investigational Cone Beam Scan

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Investigational CBCT

Radiation

Group Type OTHER

Radiation

Intervention Type RADIATION

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiation

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

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No