Honduras Liger Thermocoagulator Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervix Cancer, Cervix Lesion

Intervention / Treatment
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* Device: Liger Medical Thermocoagulator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Thermal coagulator ablation treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Thermocoagulation treatment<br>Acceptability of Liger Medical Thermocoagulator treatment | Device: Liger Medical Thermocoagulator<br>* Thermocoagulation treatment by Liger Medical device (US FDA 510K clearance received)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term Safety Concerns for Ablative Treatment | Reported a short-term adverse event. Note: Participants could report more than one discomfort or problem experienced. | 1 month after treatment | 
| Acceptability of Treatment by Women | Level of pain women experienced during the thermal coagulation procedure will be calculated by the number and percent of women indicating minimal to worst possible levels of pain using the Wong-Baker FACES® pain rating scale. Women's acceptability will also be assessed by asking if they would recommend the Liger Thermocoagulator treatment to a friend or relative who needed similar treatment as well as reasons for her response. Wong-Baker FACES® pain rating scale: MINIMUM value: 0 (no hurt = best outcome) Value: 2 (hurts little bit) Value: 4 (hurts little more) Value: 6 (hurts even more) Value: 8 (hurts lot more) MAXIMUM value: 10 (hurts whole lot = worst outcome) | Immediately after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With no Evidence of CIN2-3 Lesions 12 Months After Thermal Coagulation | Percentage of participants with no evidence of cervical intraepithelial neoplasia grade 2 or grade 3 (CIN2-3) at 12 months, based on histological evaluation following the standard criteria from WHO Classification of Tumours, 5th Edition, Volume 4: Female Genital Tumours. | One time, 12 months after treatment | 
| Treatment Failure | Qualitative analysis of cervical photos by an expert colposcopist to explore factors associated with treatment failure, compared characteristics of the cervix and precancerous lesions among women with CIN2-3 at Visit 1 (enrollment) in women whose treatment resulted in lesion disappearance (<CIN2), and women with persistent lesions (CIN2-3) at 12 months. Adequacy of the image included focus, blur, and capture; a well focused image without obstructions (blood, cysts) that captured the whole ectocervix and cervical os was considered adequate. For squamous columnar junction and transformation zone (TZ) visibility, TZ1 signifies a fully visible TZ, TZ2 signifies the TZ or visible lesions extend into the cervical canal and the TZ covers more than 75% of the ectocervix, and TZ3 signifies that the TZ is not at all visible, in accordance with WHO recommendations. Baseline histology reports histological evaluation of lesions as cervical intraepithelial neoplasia grade 2 (CIN2) or 3 (CIN3). | Once, 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thermocoagulation, Treatment, Cervical precancer