Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract

Disorder of Upper Digestive Tract Clinical Trial

Official title:

Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00544427
• Other study ID #: 20033025
• Status: Withdrawn
• Start date: August 2003
• Est. completion date: December 2020

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Optical Coherence Tomography is a minimally-invasive diagnostic tool in both the office and operating room settings can identify sources of airway obstruction and effective surgical interventions. The researcher can use Optical Coherence Tomography to image tissues of the aero-digestive tract during surgical endoscopy in to the nose, oral cavity, larynx and ear in an outpatient clinic setting.

Description:

The Optical Coherence Tomography imaging system has low power non-laser broad band infrared light shine onto laryngeal, esophageal, tracheal, oral, nasal and ear tissue and does not involve input of significant amounts of energy and no temperature rise occurs.

The gradual development and acceptance of Optical Coherence Tomography as an imaging modality serves as an alternative to invasive tissue biopsy as a diagnostic measure. Imaging diagnosis, can implement and more convenient than tissue biopsy and can reduce procedural complications.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day and older

Eligibility

Inclusion Criteria:

• Male and female age from new born to all age

Exclusion Criteria:

• subject who do not sign consent form

Related Conditions & MeSH terms

• Disorder of Upper Digestive Tract

Intervention

Device:
• Optical coherence tomography
Optical coherence tomography imaging

Locations

Country	Name	City	State
United States	Beckman Laser Institute medical Clinic,University of California,Irvine	Irvine	California
United States	Children Hospital of Orange	Orange	California
United States	Otolaryngology-Head and Neck Surgery Medical Clinic,University of California,Irvine	Orange	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine, Children's Hospital of Orange County

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic tool		up to 4 weeks