Honduras Liger Thermocoagulator Study

Cervix Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510273
• Other study ID #: 1018287
• Status: Completed
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: October 29, 2019

Study information

• Verified date: October 2019
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 29, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervix Cancer
• Cervix Lesion
• Uterine Cervical Neoplasms

Intervention

Device:
• Liger Medical Thermocoagulator
Thermocoagulation treatment by Liger Medical device (US FDA "510K" clearance received)

Locations

Country	Name	City	State
United States	PATH	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
PATH	Ashonplafa, Ministry of Health, Honduras

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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 (	Once, 12 months after treatment