NCT03510273

Honduras Liger Thermocoagulator Study

Evaluation of the Liger Medical Thermocoagulator for Treatment of Cervical Intraepithelial Lesions in Honduras

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: PATH · Academic / Other
• Sex: Female
• Age: 30 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This was a prospective study to evaluate the short-term safety and acceptability of the Liger Medical thermal coagulation device for treatment of cervical precancerous lesions. Study results will inform the Honduras Ministry of Health regarding potential use of the Liger device for precancer treatment in Honduras and results may be of interest to other Latin American settings as well. The research was conducted in the Tegucigalpa Region in Honduras in 4 health facilities in urban and peri-urban settings. Participants were women ages 30-49 who met the study eligibility criteria. Human papilloma virus (HPV) and visual inspection with acetic acid (VIA)-positive women who were eligible for ablative treatment were offered thermal coagulation with the Liger instrument to treat their lesions and asked about acceptability of the treatment. At this visit, biopsies were also be taken. Women were followed-up at 1 month to evaluate short-term safety outcomes with a physical exam and receive their biopsy results. Depending on their biopsy results, they will be asked to return for repeat screening, referred for further treatment or asked to come back for a 12-month study visit. At the 12-month visit after treatment, women were followed up to evaluate cure rates. A second investigational device, Pocket Colposcope, was used to take cervix photos at the enrollment and 12-month study visit with participant consent. The photos were used to explore factors influencing treatment failure. De-identified photos and women's diagnosis information were also shared with the device developers, Duke University, for the purposes of improving their device. Women had the option to opt out of having cervix photos taken and still participate in the treatment portion of the study.

Conditions

• Cervix Cancer
• Cervix Lesion

Interventions

Type	Name	Description
DEVICE	Liger Medical Thermocoagulator	Thermocoagulation treatment by Liger Medical device (US FDA "510K" clearance received)

Timeline

• Start date: 2018-05-04
• Primary completion: 2018-11-01
• Completion: 2019-10-29
• First posted: 2018-04-27
• Last updated: 2020-11-27
• Results posted: 2020-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study