Recruiting

Optical Spectroscopy

Sponsor:

Duke University

Code:

NCT00900575

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Optical Spectroscopy Bench-Top System

Portable Optical Spectrometer

Transvaginal colposcope

Study Details

Brief summary:

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

Conditions

Cervical Cancer

Study ID

NCT00900575

Start date

May, 2006

Status verified date

Mar, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

350 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Colposcope

Patients referred for GYN procedures. Specifically, patients will be referred for Pap smear, colposcope or LEEP. The intervention for this arm is the use of the bench-top, miniature optical spectrometer or trans-vaginal colposcope

Interventions

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

Primary outcome measure

  • Identification of optical signatures of cervical tissue [ Time Frame: Day of procedure (less than 10 minutes) ]

Central Contacts and Locations

Central contacts

Nimmi Ramanujam, Ph.D.

919-660-5307nimmi@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Nimmi Ramanujam, Ph.D.

More Information

Sponsor

Duke University

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • cervical cancer
  • LEEP
  • colposcopy
  • Pap smear

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-03-06.