Clinical trial · Interventional
Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine
Closing the Gap Between Identification and Treatment of Cervical Abnormalities in Lima, Perú Through Integraton of Pocket Colposcopy, Telemedicine and Visual Counseling
- 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)
The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. The objective is to provide colposcopy capability to rural communities in Peru potentially using Telehealth. Approximately 10,000 women will receive self HPV test kit for community health workers. Of these participants, approximately 1,000 HPV+ participants will be invited to participate in this pocket colposcopy study. Approximately 500 of these participants may require treatment using thermocoagulation.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HIV Infections | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colposcopy using pocket colpscope and thermocoagulator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV+ Pap smear
- description
- Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation.
- interventionNames
- Device: Colposcopy using pocket colpscope and thermocoagulator
Primary outcomes (1)
- measure
- Number of HPV Positive Women Examined
- timeFrame
- up to approximately 1 year
- description
- Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope
Secondary outcomes (1)
- measure
- Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: * HPV+ pap smear * Women must between the ages of 30-49yo Exclusion Criteria: * HPV (-) pap smear * people without a cervix
References
Publications (0)
Data not yet available