Study Results
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View full resultsBasic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2018-05-04
2019-10-29
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Thermocoagulation treatment
Acceptability of Liger Medical Thermocoagulator treatment
Liger Medical Thermocoagulator
Thermocoagulation treatment by Liger Medical device (US FDA "510K" clearance received)
Interventions
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Liger Medical Thermocoagulator
Thermocoagulation treatment by Liger Medical device (US FDA "510K" clearance received)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
30 Years
49 Years
FEMALE
Yes
Sponsors
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Ashonplafa
OTHER
Ministry of Health, Honduras
OTHER_GOV
PATH
OTHER
Responsible Party
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Principal Investigators
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Silvia de Sanjose, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
PATH
Locations
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PATH
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1018287
Identifier Type: -
Identifier Source: org_study_id