Clinical trial · Interventional
HRME: Screening for Cervical Cancer and Its Precursors in Low-Resource Settings
Point-of-Care, Real-Time Optical Imaging to Enable Screening for Cervical Cancer and Its Precursors in Low-Resource Settings
- 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)
A new mobile diagnostic and treatment unit is being developed by BCH to address the loss-to follow-up associated with the mobile screening program and demonstrate POC diagnosis by HRME. The mobile diagnostic and treatment unit will be equipped with the tools and infrastructure necessary to perform HRME, VIA, colposcopy, biopsy and treatment with cryotherapy. A team of a colposcopist, nurse, nursing assistant, and driver will staff the mobile diagnostic and treatment unit. The unit will travel to offer follow-up diagnostic and treatment services to women who have screened positive during a prior visit with the mobile screening unit. The mobile diagnostic and treatment unit will be constructed and maintained at BCH.
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 |
|---|---|---|---|
| Cancer Prevention | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Neoplasia of the Uterine Cervix | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Resolution Microendoscopy Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HRME - Prevention Mobile Unit
- description
- Procedures to be done in the mobile unit (van): Visual inspection will be performed with 5% acetic acid (VIA) applied to the cervix followed by standard colposcopy. Proflavine (0.01%) will then be applied topically. Lugol's solution will then be applied and colposcopy performed and abnormal lesions noted. HRME images will be acquired from any areas that are abnormal by VIA and/or colposcopy. VIA, colposcopy and HRME observations will recorded by quadrant. Any abnormal areas by VIA and/or colposcopy will be biopsied. If no abnormal areas are noted, one cervical biopsy will be obtained from a normal appearing area with a HRME image of this area obtained.
- interventionNames
- Device: High-Resolution Microendoscopy Imaging
- type
- EXPERIMENTAL
- label
- HRME - Barretos Cancer Hospital
- description
- Procedures to be done at Barretos Cancer Hospital: Visual inspection will be performed with 5% acetic acid (VIA) applied to the cervix followed by standard colposcopy. Proflavine (0.01%) will then be applied topically. Lugol's solution will then be applied and colposcopy performed and abnormal lesions noted. HRME images will be acquired from any areas that are abnormal by VIA and/or colposcopy. VIA, colposcopy and HRME observations will recorded by quadrant. Any abnormal areas by VIA and/or colposcopy will be biopsied. If no abnormal areas are noted, one cervical biopsy will be obtained from a normal appearing area with a HRME image of this area obtained.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with an abnormal Pap test (atypical squamous cells of undetermined significance or more severe interpretations \[≥ASC-US\]) 2. Women with an intact cervix (patients who have undergone previous LEEP, cone and/or cryotherapy are eligible) 3. Women of childbearing potential must have a negative urine or serum pregnancy test 4. Women who are at least 18 years of age or older 5. Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD) Exclusion Criteria: 1. Women \<18 years of age 2. Women who have undergone a hysterectomy with removal of the cervix 3. Women with a known allergy to proflavine or acriflavine 4. Women who are pregnant or nursing 5. Women unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)
References
Publications (0)
Data not yet available