Honduras Liger Thermocoagulator Study

P

People Acting To Help (PATH)

Status

Completed

Conditions

Cervix Lesion
Cervix Cancer

Treatments

Device: Liger Medical Thermocoagulator

Study type

Interventional

Funder types

Other

Identifiers

NCT03510273
1018287

Details and patient eligibility

About

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.

Enrollment

320 patients

Sex

Female

Ages

30 to 49 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

320 participants in 1 patient group

Thermocoagulation treatment
Other group
Description:
Acceptability of Liger Medical Thermocoagulator treatment
Treatment:
Device: Liger Medical Thermocoagulator

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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