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Device

Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia (MDCwProbe Trial)

N/A
Waitlist Available
Led By Michele Follen, MD, PhD
Research Sponsored by Brookdale University Hospital Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at point of care for colposcopy or treatment with leep (5 minutes).
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Cervical Neoplasia
  • Cervical Dysplasia
  • Cervical Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at point of care for colposcopy or treatment with leep (5 minutes).
This trial's timeline: 3 weeks for screening, Varies for treatment, and at point of care for colposcopy or treatment with leep (5 minutes). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Detection of precancerous cervical lesions or cervical cancer

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Routine colposcopy and MDC with probeExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Brookdale University Hospital Medical CenterLead Sponsor
8 Previous Clinical Trials
2,580 Total Patients Enrolled
Michele Follen, MD, PhDPrincipal InvestigatorBrookdale University Hospital and Medical Center
8 Previous Clinical Trials
1,312 Total Patients Enrolled
1 Trials studying Cervical Dysplasia
3 Patients Enrolled for Cervical Dysplasia
~57 spots leftby Dec 2025