Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Dysplasia

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Acceptability of Liger Medical Thermocoagulator treatment

Thermocoagulation treatment by Liger Medical device (US FDA "510K" clearance received)

Liger Medical Thermocoagulator

Silvia de Sanjose, MD, PhD

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.

Honduras Liger Thermocoagulator Study

Evaluation of the Liger Medical Thermocoagulator for Treatment of Cervical Intraepithelial Lesions in Honduras

Reported a short-term adverse event. Note: Participants could report more than one discomfort or problem experienced.

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)

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.

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).

Ashonplafa

Ministry of Health, Honduras

PATH

Received thermal coagulation treatment for cervical precancer.

Thermocoagulation Treatment

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Honduras

Region of Enrollment

No differences from the assignment in the Participant Flow section.

Dr. Silvia de Sanjose

Colorless watery discharge

Brown/black discharge

Foul-smelling, pus-colored discharge

Bleeding

Pain while urinating

Severe lower abdominal pain

Fever

All participants were included. Note: Participants could report more than one discomfort or problem experienced.

Short-term Safety Concerns for Ablative Treatment

FACES® level of pain: 0 - no hurt

FACES® level of pain: 2 - hurts little bit

FACES® level of pain: 4 - hurts little more

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

Not applicable; all participants were included.

Acceptability of Treatment by Women

CIN2-3 at Baseline

< CIN2 at Baseline

Percentage of Participants With no Evidence of CIN2-3 Lesions 12 Months After Thermal Coagulation

Baseline photo: Adequate

Baseline photo: Inadequate

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

Women with CIN2-3 at baseline and CIN2-3 at 12 months

Evidence of Treatment Failure

Women with CIN2-3 at baseline and \<CIN2 at 12 months

No Evidence of Treatment Failure

Treatment Failure

Overall Study

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