Cervix CancerNCT03510273
Honduras Liger Thermocoagulator Study
A study testing Liger Medical Thermocoagulator in people with Cervix Cancer and Cervix Lesion, run by PATH at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 30 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix Cancer, Cervix Lesion
- What is being tested?
- Liger Medical Thermocoagulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2018to 29 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Liger Medical Thermocoagulator for Treatment of Cervical Intraepithelial Lesions in Honduras
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.
- Conditions
- Cervix Cancer, Cervix Lesion
- Being tested
- Liger Medical Thermocoagulator
- Keywords
- Thermocoagulation, Treatment, Cervical precancer
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liger Medical ThermocoagulatorDevice
Thermocoagulation treatment by Liger Medical device (US FDA "510K" clearance received)
| Study group | Role | What they receive |
|---|---|---|
| Thermocoagulation treatment | Other | Acceptability of Liger Medical Thermocoagulator treatment Receives: Device: Liger Medical Thermocoagulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term Safety Concerns for Ablative Treatment
Reported a short-term adverse event. Note: Participants could report more than one discomfort or problem experienced.
Measured: 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)
Measured: Immediately after treatment
Secondary outcomes (2)
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.
Measured: 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).
Measured: Once, 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start4 May 2018
- Primary completion1 Nov 2018
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Thermal coagulator ablation treatment
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Ashonplafa, Ministry of Health, Honduras
- Responsible party
- Sponsor
- Investigators
- Silvia de Sanjose, MD, PhD, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510273
- Sponsor's protocol ID
- 1018287
- Status last verified
- Oct 2019
- First submitted
- 17 Apr 2018
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Liger Medical Thermocoagulator for Treatment of Cervical Intraepithelial Lesions in Honduras
- ClinicalTrials.gov ID
- NCT03510273
- Acronym / sponsor ID
- 1018287
- Conditions
- Cervix Cancer, Cervix Lesion
- Keywords
- Thermocoagulation, Treatment, Cervical precancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Ashonplafa, Ministry of Health, Honduras
- Study start
- 4 May 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Posted 6 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Thermal coagulator ablation treatment
| Arm | Type | Receives |
|---|---|---|
| Thermocoagulation treatment | Other | Device: Liger Medical ThermocoagulatorAcceptability of Liger Medical Thermocoagulator treatment |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women
- Aged 30 to 49 years.
- HPV and VIA positive.
- Eligible for ablative treatment using World Health Organization Guidelines [29].
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liger Medical ThermocoagulatorThermocoagulation treatment by Liger Medical device (US FDA "510K" clearance received) | Device | Thermocoagulation treatment |
Primary outcome
Short-term Safety Concerns for Ablative Treatment
Time frame: 1 month after treatment
Reported a short-term adverse event. Note: Participants could report more than one discomfort or problem experienced.
Acceptability of Treatment by Women
Time frame: Immediately after treatment
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)
2 secondary outcomes
Percentage of Participants With no Evidence of CIN2-3 Lesions 12 Months After Thermal Coagulation
Time frame: One time, 12 months after treatment
Treatment Failure
Time frame: Once, 12 months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia de Sanjose, MD, PhD principal investigator
PATH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liger Medical Thermocoagulator in people with Cervix Cancer and Cervix Lesion, run by PATH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term Safety Concerns for Ablative Treatment (time frame: 1 month after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.