Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine

NCT05340322 | Completed Results FDA Device

• 1 other identifier: Pro00106490
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cervical Cancer; HPV Infection; HIV Infections

Keywords

cervical cancer screening; Pap smear; colposcopy

Outcome Measures

Primary Outcomes (1)

• Number of HPV Positive Women Examined

  Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope

  up to approximately 1 year

Secondary Outcomes (1)

• Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment

  6 months after initial visit

Study Arms (1)

HPV+ Pap smear

EXPERIMENTAL

Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation.

Device: Colposcopy using pocket colpscope and thermocoagulator

Interventions

Colposcopy using pocket colpscope and thermocoagulator DEVICE

If HPV+, visualization with pocket colposcope and treatment with thermocoagulator

HPV+ Pap smear

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HPV+ pap smear
• Women must between the ages of 30-49yo

You may not qualify if:

• HPV (-) pap smear
• people without a cervix

Sponsors & Collaborators

• Duke University: lead
• United States Agency for International Development (USAID): collaborator
• Universidad Peruana Cayetano Heredia: collaborator

Study Sites (1)

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; HIV Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Nimmi Ramanujam, PhD
• Organization: Duke University

nimmi@duke.edu

9196605307

Study Officials

• Nimmi Ramanujam, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 22, 2022
• Study Start: May 1, 2022
• Primary Completion: April 15, 2023
• Study Completion: October 15, 2023
• Last Updated: July 23, 2024
• Results First Posted: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)