Clinical trial · Interventional
Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia
Development and Application of a Multispectral Digital Colposcope and Probe Algorithm for Detection of Cervical Intraepithelial Neoplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma in Situ of Uterine Cervix | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasias | — | UNRESOLVED | — |
| High Grade Cervical Intraepithelial Neoplasia | High Grade Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multispectral Digital Colposcope with probe | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Routine colposcopy and MDC with probe
- description
- 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.
- interventionNames
- Device: Multispectral Digital Colposcope with probe
Primary outcomes (1)
- measure
- Detection of precancerous cervical lesions or cervical cancer
- timeFrame
- At point of care for colposcopy or treatment with LEEP (5 minutes).
- description
- Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the MDC with probe will also be used to collect images of the cervix and spectroscopic measurements with the probe. All measurements will be compared with the biopsies obtained. The MDC with probe will not be used to determine from where the biopsies need to be obtained. One or two additional biopsies will be obtained from tissue that appears to be unaffected. These will be the control biopsies. Patients may refuse to provide the additional biopsies which are not part of the standard of care. Patients scheduled for a treatment with the Loop Electrosurgical Excision Procedure (LEEP) will be asked for consent to obtain one or two biopsies prior to the LEEP procedure, but after anesthesia has been applied.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available