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Cervical Cancer Detection Using Optical Spectroscopy

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ClinicalTrials.gov Identifier: NCT00900575
Recruitment Status : Recruiting
First Posted : May 13, 2009
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Cervical Cancer Device: Optical Spectroscopy Bench-Top System Device: Portable Optical Spectrometer Device: Transvaginal colposcope Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cervical Cancer Detection Using Optical Spectroscopy
Study Start Date : May 2006
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Duke Arm
patients referred for colposcopically directed biopsy or LEEP. The intervention for this arm is the use of the bench-top, miniature optical spectrometer or trans-vaginal colposcope
Device: Optical Spectroscopy Bench-Top System
This device is a bench-top optical spectrometer
Device: Portable Optical Spectrometer
This device is a portable optical spectrometer
Device: Transvaginal colposcope
Other Names:
  • TVDC
  • Transvaginal digital colposcope



Primary Outcome Measures :
  1. Identification of optical signatures of cervical tissue [ Time Frame: Day of procedure (less than 10 minutes) ]
    The primary outcome of this study is the identification of the optical signatures of cervical tissue.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • undergoing colposcopy for the diagnosis of cervical cancer
  • LEEP for the treatment of cervical cancer in early stages.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900575


Contacts
Contact: Nimmi Ramanujam, Ph.D. 919-660-5307 nimmi@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Nimmi Ramanujam, Ph.D.         
Sub-Investigator: John Schmitt, M.D.         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Nimmi Ramanujam, Ph.D. Duke University

Additional Information:
Publications of Results:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00900575     History of Changes
Other Study ID Numbers: Pro00008173
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Duke University:
cervical cancer
LEEP
colposcopy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female