Honduras Liger Thermocoagulator Study

NCT03510273 | Completed Results FDA Device

• 1 other identifier: 1018287
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Thermocoagulation; Treatment; Cervical precancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

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

  One time, 12 months after treatment

• Treatment Failure

  Once, 12 months after treatment

Study Arms (1)

Thermocoagulation treatment

OTHER

Acceptability of Liger Medical Thermocoagulator treatment

Device: Liger Medical Thermocoagulator

Interventions

Liger Medical Thermocoagulator DEVICE

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

Thermocoagulation treatment

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PATH: lead
• Ashonplafa: collaborator
• Ministry of Health, Honduras: collaborator

Study Sites (1)

PATH

Seattle, Washington, 98121, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Results Point of Contact

• Title: Dr. Silvia de Sanjose
• Organization: PATH

sdesanjose@path.org

2062853500

Study Officials

• Silvia de Sanjose, MD, PhD

  PATH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Thermal coagulator ablation treatment

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 27, 2018
• Study Start: May 4, 2018
• Primary Completion: November 1, 2018
• Study Completion: October 29, 2019
• Last Updated: November 27, 2020
• Results First Posted: March 6, 2020

Record last verified: 2019-10

Locations

US (1)