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Development and Application of a Multispectral Digital Colposcopy Algorithm for Detection of Cervical Intraepithelial Neoplasia and Neoplasia.


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Precancerous Condition

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Trial Information

Development and Application of a Multispectral Digital Colposcopy Algorithm for Detection of Cervical Intraepithelial Neoplasia and Neoplasia.

Inclusion Criteria


Inclusion criteria:

- Included subjects will be ≥18 years old.

- Included subjects will not be pregnant.

- Included subjects will have a negative urine pregnancy test.

- Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH
Women's Clinic.

- Included subjects will indicate understanding of the study.

- Included subjects will provide informed consent to participate.

Exclusion criteria:

- Individuals <18 years old will be excluded.

- Pregnant individuals will be excluded.

- Individuals that have had an operation to remove their cervix will be excluded.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Detection of cancer or pre-cancerous abnormalities of the cervix by multispectral digital colposcope.

Outcome Description:

All study subjects will be evaluated for cervical abnormalities by 1) standard colposcopy and 2) the trial device (multispectral digital colposcope + wand). Results from each device will be compared, both in terms of the presence/absence of abnormalities and the stage/grade of abnormalities detected by both tools. Histopathological review for cervical abnormalities will be taken as the gold standard against which standard colposcopy and trial device results are measured.

Outcome Time Frame:

Standard colposcopy and trial device (MDC + wand) results will be obtained during the clinic visit. Histopathological results for comparison will be available within a few days of the clinic visit.

Safety Issue:

No

Principal Investigator

Michele Follen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Drexel University

Authority:

United States: Institutional Review Board

Study ID:

BCCR-H09-03303

NCT ID:

NCT01094132

Start Date:

December 2012

Completion Date:

March 2016

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 1
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Nonmalignant Condition
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

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