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| Name | Class |
|---|---|
| Ashonplafa | OTHER |
| Ministry of Health, Honduras | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermocoagulation treatment | Other | Acceptability of Liger Medical Thermocoagulator treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liger Medical Thermocoagulator | Device | Thermocoagulation treatment by Liger Medical device (US FDA "510K" clearance received) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Women
Aged 30 to 49 years.
HPV and VIA positive.
Eligible for ablative treatment using World Health Organization Guidelines [29].
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia de Sanjose, MD, PhD | PATH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PATH | Seattle | Washington | 98121 | United States |
One woman was positive for visual inspection with acetic acid, but after enrollment was found to not have documentation of her human papillomavirus test or test result. Therefore, 320 were enrolled but only 319 participated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Thermocoagulation Treatment | Received thermal coagulation treatment for cervical precancer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No differences from the assignment in the Participant Flow section.
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| ID | Title | Description |
|---|---|---|
| BG000 | Thermocoagulation Treatment | Received thermal coagulation treatment for cervical precancer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants were included. Note: Participants could report more than one discomfort or problem experienced. | Posted | Number | participants | 1 month after treatment |
|
|
Between 1 day and 12 months+1 day, depending on when the patient exited the study for any reason.
Self-reported patient data
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thermocoagulation Treatment | Received thermal coagulation treatment for cervical precancer. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High pain during procedure | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Silvia de Sanjose | PATH | 2062853500 | sdesanjose@path.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2019 | Jan 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Thermal coagulator ablation treatment
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| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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) | Not applicable; all participants were included. | Posted | Count of Participants | Participants | 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. | Posted | Number | 95% Confidence Interval | % participants | 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 (\ | Posted | Count of Participants | Participants | Once, 12 months after treatment |
|
|
|
|
| 0 |
| 319 |
| 0 |
| 319 |
| 308 |
| 319 |
| Mild bleeding/spotting during procedure (not requiring medical attention) | Reproductive system and breast disorders | Systematic Assessment |
|
| Mild cramping during procedure (not requiring medical attention) | Reproductive system and breast disorders | Systematic Assessment |
|
| Dizziness during procedure (not requiring medical attention) | General disorders | Systematic Assessment |
|
| Colorless water discharge within 30 days of procedure (not requiring medical attention) | Reproductive system and breast disorders | Systematic Assessment |
|
| Brown/black discharge within 30 days of procedure (not requiring medical attention) | Reproductive system and breast disorders | Systematic Assessment |
|
| Foul smelling, pus colored discharge within 30 days of procedure (not requiring medical attention) | Reproductive system and breast disorders | Systematic Assessment |
|
| Bleeding within 30 days of procedure (not requiring medical attention) | Reproductive system and breast disorders | Systematic Assessment |
|
| Attended health facility or saw health provider because of problems. | Reproductive system and breast disorders | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |
| Title | Measurements |
|---|---|
|
| FACES® level of pain: 6 - hurts even more |
|
| FACES® level of pain: 8 - hurts whole lot |
|
| FACES® level of pain: 10 - hurts worst |
|
| Would recommend treatment to friend/relative |
|
| Would not recommend treatment to friend/relative |
|
| Squamous columnar junction visibility: TZ1 |
|
| Squamous columnar junction visibility: TZ2 |
|
| Squamous columnar junction visibility: TZ3 |
|
| Squamous columnar junction visibility: Missing |
|
| Visible abnormal areas: 0 |
|
| Visible abnormal areas: 1 |
|
| Visible abnormal areas: 2+ |
|
| Visible abnormal areas: Not evaluable |
|
| Visible abnormal areas: Missing |
|
| Location of the lesion: Inside the TZ |
|
| Location of the lesion: Outside the TZ |
|
| Location of the lesion: Not evaluable |
|
| Mosaic of the worst lesion: Fine |
|
| Mosaic of the worst lesion: Coarse |
|
| Mosaic of the worst lesion: No mosaic |
|
| Mosaic of the worst lesion: Not evaluable |
|
| Border of the worst lesion: Irregular |
|
| Border of the worst lesion: Sharp |
|
| Border of the worst lesion: Not evaluable |
|
| Possible diagnosis: No lesion |
|
| Possible diagnosis: LSIL |
|
| Possible diagnosis: HSIL |
|
| Possible diagnosis: Invasion |
|
| Possible diagnosis: Not evaluable |
|
| Baseline histology: CIN2 |
|
| Baseline histology: CIN3 |
|
| Size of worst lesion (% coverage): 0-4 |
|
| Size of worst lesion (% coverage): 5-50 |
|
| Size of worst lesion (% coverage): >50 |
|
| Other |
Type of statistical test: Independence Description: Squamous columnar junction visibility |
| Fisher Exact | 0.774 | Other | Type of statistical test: Independence Description: Visible abnormal areas |
| Fisher Exact | 1 | Other | Type of statistical test: Independence Description: Location of the lesion |
| Fisher Exact | 0.36 | Other | Type of statistical test: Independence Description: Mosaic of the worst lesion |
| Fisher Exact | 0.881 | Other | Type of Statistical Test: Independence Description: Acetowhite changes |
| Fisher Exact | 0.829 | Other | Type of Statistical Test: Independence Description: Border of the worst lesion |
| Fisher Exact | 1 | Other | Type of Statistical Test: Independence Description: Possible diagnosis |
| Fisher Exact | 1 | Other | Type of Statistical Test: Independence Description: Baseline histology |
| Fisher Exact | 0.493 | Other | Type of Statistical Test: Independence Description: Size of the worst lesion (% coverage) |