Honduras Liger Thermocoagulator Study

Status Completed

Clinical 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03510273
Study type	Interventional
Source	PATH
Contact
Status	Completed
Phase	N/A
Start date	May 4, 2018
Completion date	October 29, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04067882` - Validation of the Genetic Signature 354849 as a Prognostic Method
Completed	`NCT00329589` - A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients	Phase 1
Recruiting	`NCT05743517` - Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)	N/A
Completed	`NCT05234112` - Prevention and Screening Towards Elimination of Cervical Cancer	N/A
Completed	`NCT04258553` - Thiol Disulfide Balance in Cervix Cancer
Completed	`NCT03956498` - Impact of a Sexological Follow-up on the Sexual Function in Patients With Cervix or Vaginal Cancer Treated by Radiotherapy and Brachytherapy	N/A
Active, not recruiting	`NCT04357873` - Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations	Phase 2
Completed	`NCT00379743` - Partnership for Healthy Seniors	N/A
Completed	`NCT00509444` - Cancer Prevention and Treatment Among African American Older Adults: Treatment Trial	Phase 3
Recruiting	`NCT06022029` - A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.	Phase 1
Recruiting	`NCT06116019` - Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)
Completed	`NCT04072913` - Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix	N/A
Active, not recruiting	`NCT06452004` - Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)	N/A
Recruiting	`NCT04651127` - Anti-PD-1 Antibody Combined With Histone Deacetylase Inhibitor in Patients With Advanced Cervical Cancer	Phase 1/Phase 2
Recruiting	`NCT06010875` - A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors	Phase 1
Completed	`NCT02552121` - Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors	Phase 1/Phase 2
Completed	`NCT02001623` - Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors	Phase 1/Phase 2
Completed	`NCT02997553` - Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery	Phase 3
Terminated	`NCT02233387` - PET CT With HX4 in Cervix Cancer	Phase 2
Completed	`NCT01766284` - Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix	N/A