Recruiting

Digital Colposcope

Sponsor:

Brookdale University Hospital Medical Center

Code:

NCT02406352

Conditions

Carcinoma in Situ of Uterine Cervix

Cervical Intraepithelial Neoplasias

High Grade Cervical Intraepithelial Neoplasia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multispectral Digital Colposcope with probe

Study Details

Brief summary:

Although cervical cancer is a preventable cancer, every year more than one-quarter of a million women die worldwide from this disease. Internationally and nationally, cervical cancer is a disease that affects predominantly women who are poor and who live in resource poor settings. With the device the investigators are developing, known as the Multispectral Digital Colposcope with probe, our goal is to make detection of precancerous cervical lesions easier for the patient and for her provider. For the patient, our goal is to reduce the number of clinical visits needed to obtain a diagnosis and treatment and consequently to reduce the resulting fear and anxiety which usually accompanies an abnormal Pap smear. For the provider and the health care system, our goal is to obtain a more accurate diagnosis than the currently available diagnostic methods.

Conditions

Carcinoma in Situ of Uterine Cervix

Cervical Intraepithelial Neoplasias

High Grade Cervical Intraepithelial Neoplasia

Study ID

NCT02406352

Start date

Mar, 2015

Status verified date

Apr, 2015

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women who are at least 18 years old
  • Are not pregnant (negative urine test) or breastfeeding
  • Referred for colposcopy or LEEP treatment
  • Can provide written informed consent

Exclusion Criteria:

  • Women who do not meet the inclusion criteria
  • Women who have had a hysterectomy

Study Design

Enrollment

618 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Routine colposcopy and MDC with probe

The intervention which consists of obtaining cervical images with the MDC and spectroscopic data with the probe will be applied to all participants who agreed to participate in the study during their visit for a colposcopy exam or treatment with a LEEP procedure. A control biopsy will also be obtained from patients who agree to provide it. The control biopsy is a biopsy of cervical tissue that does not appear to have atypical changes when observed through a standard of care colposcope.

Interventions

Multispectral Digital Colposcope with probe

Cervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study.

The standard of care for research participants will not change.

Primary outcome measure

  • Detection of precancerous cervical lesions or cervical cancer [ Time Frame: At point of care for colposcopy or treatment with LEEP (5 minutes). ]

Central Contacts and Locations

Central contacts

Locations

Brookdale University Hospital and Medical Center

Recruiting

Brooklyn, New York, United States, 11212

Contacts

Principal Investigator:

Michele Follen, MD, PhD

More Information

Sponsor

Brookdale University Hospital Medical Center

Last update posted

Apr 10, 2015

Last verified

Apr, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brookdale University Hospital Medical Center on 2015-04-10.