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NCT Number: NCT00900575

Cervical Cancer Detection Using Optical Spectroscopy

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

Recruiting

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

John Schmitt, M.D.

SUB_INVESTIGATOR

Nimmi Ramanujam, Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical Spectroscopy Bench-Top System

Device

This device is a bench-top optical spectrometer

Portable Optical Spectrometer

Device

This device is a portable optical spectrometer

Transvaginal colposcope

Device

Other names: TVDC, Transvaginal digital colposcope, Pocket colposcope, callascope

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nimmi Ramanujam, Ph.D.

CONTACT

[email protected]

919-660-5307

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2006
Primary completion
2028
Study completion
2028
First posted
May 13, 2009
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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