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NCT00900575 Clinical Trial

Cervical Cancer Detection Using Optical Spectroscopy

Cervical Cancer Clinical Trial

Official title:
Cervical Cancer Detection Using Optical Spectroscopy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00900575
Other study ID # Pro00008173
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2006
Est. completion date January 31, 2025

Study information
Verified date January 2024
Source Duke University
Contact Nimmi Ramanujam, Ph.D.
Phone 919-660-5307
Email nimmi@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

Recruitment information / eligibility
Status Recruiting
Enrollment 350
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - undergoing colposcopy for the diagnosis of cervical cancer - LEEP for the treatment of cervical cancer in early stages. - Follow-up Pap smear in surveillance Exclusion Criteria: - Women under the age of 18 (minors) will be excluded from this study. - patients will be excluded if she has had a recent episode of bleeding or preterm labor. - Subjects who are not competent to give consent will excluded

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Optical Spectroscopy Bench-Top System
This device is a bench-top optical spectrometer
• Portable Optical Spectrometer
This device is a portable optical spectrometer
• Transvaginal colposcope

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chang VT, Cartwright PS, Bean SM, Palmer GM, Bentley RC, Ramanujam N. Quantitative physiology of the precancerous cervix in vivo through optical spectroscopy. Neoplasia. 2009 Apr;11(4):325-32. doi: 10.1593/neo.81386. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of optical signatures of cervical tissue The primary outcome of this study is the identification of the optical signatures of cervical tissue. Day of procedure (less than 10 minutes)
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