Clinical trial NCT03510273: Honduras Liger Thermocoagulator Study
Official title: Evaluation of the Liger Medical Thermocoagulator for Treatment of Cervical Intraepithelial Lesions in Honduras
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervix Cancer
Cervix Lesion
Keywords: Thermocoagulation
Treatment
Cervical precancer
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Ashonplafa
name: Ministry of Health, Honduras
First posted: 2018-04-27
Enrollment: 320
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Thermal coagulator ablation treatment
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

Women

* Aged 30 to 49 years.
* HPV and VIA positive.
* Eligible for ablative treatment using World Health Organization Guidelines \[29\].

  * The lesion covers \<75% of the cervix, the lesion does not enter the endocervical canal, the entire lesion can be visualized and covered by the Liger Medical Thermocoagulator probe, and there is no suspicion for invasive cancer.

Exclusion Criteria:

* Are pregnant or less than 3 months post-partum
* Are not HPV and VIA positive
* Do not have a cervical lesion that qualifies for ablative treatment
* Have a bleeding disorder or taking anti-coagulant medication.
* Do not give informed consent; or unable to provide the consent.

Primary outcomes:
measure: Short-term Safety Concerns for Ablative Treatment
timeFrame: 1 month after treatment
measure: Acceptability of Treatment by Women
timeFrame: Immediately after treatment
Secondary outcomes:
measure: Percentage of Participants With no Evidence of CIN2-3 Lesions 12 Months After Thermal Coagulation
timeFrame: One time, 12 months after treatment
measure: Treatment Failure
timeFrame: Once, 12 months after treatment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: PATH
state: Washington
Study officials:
affiliation: PATH
name: Silvia de Sanjose, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: