Honduras Liger Thermocoagulator Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 30 - 49 |
| Updated: | 10/28/2018 |
| Start Date: | May 4, 2018 |
| End Date: | December 2019 |
Evaluation of the Liger Medical Thermocoagulator for Treatment of Cervical Intraepithelial Lesions in Honduras
This is 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 will be conducted in the Tegucigalpa Region in Honduras in 4 health facilities
in urban and peri-urban settings. Participants will be women ages 30-49 who meet the study
eligibility criteria. HPV and VIA positive women who are eligible for ablative treatment will
be offered thermal coagulation with the Liger instrument to treat their lesions and ask about
acceptability of the treatment. At this visit, biopsies will also be taken. Women will then
be 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 will be followed up to evaluate cure
rates.
A second investigational device, Pocket Colposcope, will be used to take cervix photos at the
first study visit with participant consent. The photos will be used to explore factors
influencing treatment failure. De-identified photos and women's diagnosis information will
also be shared with the device developers, Duke University, for the purposes of improving
their device. Women may choose to opt out of having cervix photos taken and still participate
in the treatment portion of the study.
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 will be conducted in the Tegucigalpa Region in Honduras in 4 health facilities
in urban and peri-urban settings. Participants will be women ages 30-49 who meet the study
eligibility criteria. HPV and VIA positive women who are eligible for ablative treatment will
be offered thermal coagulation with the Liger instrument to treat their lesions and ask about
acceptability of the treatment. At this visit, biopsies will also be taken. Women will then
be 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 will be followed up to evaluate cure
rates.
A second investigational device, Pocket Colposcope, will be used to take cervix photos at the
first study visit with participant consent. The photos will be used to explore factors
influencing treatment failure. De-identified photos and women's diagnosis information will
also be shared with the device developers, Duke University, for the purposes of improving
their device. Women may choose to opt out of having cervix photos taken and still participate
in the treatment portion of the study.
Inclusion Criteria:
Women
- Aged 30 to 49 years.
- HPV and VIA positive.
- Eligible for ablative treatment using WHO 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.
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