San Salvador

Researchers are evaluating the Polaris System, a robotic device designed to assist surgeons in performing cataract surgery with improved precision and safety. This early feasibility, prospective, single-arm study focuses on patients aged 40 to 75 with uncomplicated, age-related cataracts. The goal is to assess the safety of the Polaris System by monitoring the rate of safety events over a 12-week period. Participants will undergo robot-assisted cataract surgery using the Polaris System. The procedure involves standard intraoperative eye preparation under general anesthesia, followed by docking the study eye to the device. The surgeon will use the Polaris System to perform initial surgical tasks, lens extraction, and intraocular lens implantation. After surgery, participants will have four scheduled follow-up visits over 90 days to monitor recovery and outcomes. During the study, participants will be evaluated through clinical examinations and safety assessments. Researchers will track surgical safety events up to 12 weeks after intervention to understand the devices safety profile. Participants must adhere to all study procedures, including medication regimens to prevent inflammation and infection, and attend scheduled follow-up visits. The total participation period includes the surgery and a 90-day follow-up phase.

Researchers are evaluating two different management protocols for children aged 1 to 12 years with severe traumatic brain injury sTBI in Latin America. The study aims to determine if using a treatment approach guided by invasive intracranial pressure ICP monitoring leads to better outcomes compared to a protocol based solely on imaging and clinical exams. This trial builds on previous adult studies and addresses the unique needs of pediatric patients to improve care and guide global clinical practice. The study randomly assigns children to one of two treatment groups. One group receives care following a protocol that uses invasive ICP monitoring to guide management decisions, based on recommendations from the Brain Trauma Foundation Guidelines. The other group follows the CREVICE protocol, which manages sTBI using imaging and clinical examination without ICP monitoring. Both protocols focus on aggressive management of sTBI. The trial is conducted in eight pediatric intensive care units in Latin America, aiming to strengthen research skills among local pediatric intensivists. Participants will be closely monitored during their hospital stay, with the study measuring outcomes such as quality of life using the Pediatric Quality of Life Inventory PedsQL at three and six months, functional recovery with the Glasgow Outcome Scale - Extended Pediatric GOS-E Peds, mortality rates, brain-specific treatments, and length of stay in intensive care. Data will be collected for up to six months after injury to assess the effects of the two management strategies on recovery and complications.

Researchers are evaluating the safety and usability of a new intraocular lens IOL called AAL-FAIOL for adults who need cataract surgery in both eyes. The study is conducted in Central America and aims to compare the AAL-FAIOL lens with another lens called BAL-FAIOL. The goal is to explore how well these lenses work and how safe they are for long-term use after cataract removal. Participants will have cataract surgery in both eyes, with one eye receiving the AAL-FAIOL lens and the other eye receiving the BAL-FAIOL lens. The surgeries in the two eyes will be scheduled 14 to 35 days apart. The AAL-FAIOL lens can be adjusted after surgery using laser treatment if needed to improve vision. Both lenses are implanted during cataract surgery using a technique called phacoemulsification. During the study, participants will attend follow-up visits for about one year to monitor their eye health and vision. Researchers will check for any eye-related adverse events or complications, including any additional surgeries needed. The study will measure the overall safety of the lenses and how well participants do over this 12-month period after their surgeries.

Researchers are evaluating an organ dysfunction score adapted specifically for pregnant and early postpartum patients up to 3 days after birth admitted to intensive care units ICU. This observational study aims to determine if this adjusted score, called SOFA-OBS, better predicts ICU mortality compared to the general SOFA score. The study also assesses whether a non-invasive pulse oximeter can effectively evaluate respiratory function instead of the standard arterial blood gas test, which is more painful and invasive. The study involves following pregnant and postpartum patients admitted to the ICU for at least 24 hours. Researchers will collect routine clinical data and laboratory results already used in ICU care, without requiring extra interventions. The SOFA-OBS score adjusts kidney function and blood pressure measurements to reflect the physiological changes during pregnancy and postpartum. It also replaces arterial blood gas oxygen measurements with pulse oximetry when blood gas analysis is unavailable. Data will be recorded daily during the ICU stay. Participants will be monitored for organ dysfunction and mortality outcomes during their ICU stay or up to 28 days after enrollment. Researchers will evaluate and compare the predictive ability of the SOFA-OBS and general SOFA scores for ICU mortality and sepsis-related death. Data quality will be carefully checked, and privacy will be protected by anonymizing patient information. The study is approved by ethical boards and requires informed consent from participants, with a planned enrollment of 130 patients.

Researchers are evaluating a modified thermal ablation treatment using the IRIS173 device and an AI-based Automated Visual Evaluation AVE triage algorithm among HPV-positive women in El Salvador. This study aims to estimate the 1-year cure rates of cervical intraepithelial neoplasia grade 2 or higher CIN2 after treatment and to assess how well the AVE algorithm identifies high-risk cervical images compared to tissue analysis. The trial addresses the need for improved protocols in treating cervical precancer with portable thermal ablation devices in low-resource settings. Participants eligible for ablation will receive thermal ablation using the IRIS173 device with a modified two-probe protocol. The treatment involves placing a short endocervical probe inside the cervical canal for 20 seconds at 1001730C, followed by overlapping applications of a flat ectocervical probe for 20 seconds each until the entire targeted area is treated. Some women will be monitored for side effects at 6 weeks and for safety at 4-6 months post-treatment. Women not eligible for ablation will be referred for standard care. A retrospective analysis will also evaluate the AVE algorithms performance using cervical images and biopsy results. Participants will undergo an initial visit with HPV genotyping, visual assessment, colposcopy, biopsies, and endocervical curettage. Those treated will be asked to return at one year for follow-up testing including HPV genotyping and biopsies to check for persistent disease. A subsample will have additional visits for safety monitoring. Biopsy samples will be reviewed by expert pathologists to confirm diagnoses. Researchers will measure cure rates, side effects, participant acceptability, and diagnostic accuracy of the AVE algorithm, with the total study duration lasting up to one year post-treatment for most participants.

Cervical cancer remains a major health challenge, especially in low- and middle-income countries where over 90% of cases occur. Current global strategies aim to eliminate cervical cancer by 2030, but many regions may not meet these goals until much later. This trial evaluates a new rapid and affordable screening method using the AmpFireae human papillomavirus HPV test combined with artificial intelligence-based imaging triage Automated Visual Evaluation, AVE to improve early detection and treatment in Honduras. The study involves testing 4,000 women with both self- and provider-collected samples using the modified AmpFireae platform to detect cervical precancer. Women who test positive or a small random sample of negatives will undergo further examination including visual inspection with acetic acid VIA, AVE, colposcopy, and biopsy. HPV-positive women may receive immediate ablation treatment if eligible. Additionally, 1,000 women will participate in a single-visit screening approach using self-sampling with follow-up testing one year later. The study also assesses the cost-effectiveness of the new approach compared to the current VIA strategy. Participants will complete questionnaires on acceptability and experience, and healthcare providers will be surveyed on the screening process. Follow-up visits at one year will include repeat HPV testing, AVE, and colposcopy for HPV-positive women. Outcomes measured include test accuracy, feasibility of same-day screening and treatment, and economic impact. Safety and quality of pathology review are monitored throughout. The total study duration for primary outcomes is two years.

Cervical cancer rates have dropped significantly in high-income countries due to prevention strategies, but low- and middle-income countries still bear most of the global burden, with about 85% of new cases and 90% of deaths. Screening is vital to reduce this burden, and the World Health Organization recommends human papillomavirus HPV testing as the best method. However, HPV testing can be costly and complex, often requiring women to return for results and treatment, which leads to many being lost to follow-up, especially in resource-limited settings. This study evaluates a same-day screen-and-treat approach using a low-cost HPV test called ScreenFire, compared to the standard two-visit approach, in El Salvador. Women will self-collect samples for HPV testing, and if needed, receive treatment on the same day. The study will enroll 1,000 women aged 30 to 59 years from remote areas over 10 to 15 weeks to see if the single-visit method reduces loss to follow-up. Participants will be followed for six months to measure how many return for care, with the main focus on the proportion lost to follow-up at six months. The study includes assessments of adherence to the screening program and the feasibility of local processing of the HPV test. The research team will monitor outcomes related to the effectiveness of the single-visit screening and treatment strategy, aiming to improve cervical cancer prevention in low-resource settings.

This research aims to evaluate the safety and effectiveness of the Vizio Aqueous Microshunt, a medical device developed to treat refractory glaucoma by lowering intraocular pressure IOP to a level that may prevent further optic nerve damage without needing additional medications. Glaucoma is a major cause of irreversible blindness, and current drainage devices often still require medication. The Vizio device represents a next-generation technology developed to improve upon earlier devices with better healing and implantation techniques. Participants will receive the Vizio Aqueous Microshunt, which drains aqueous humor from the eyes anterior chamber to the eye surface, potentially improving IOP control predictability and reducing ocular surface symptoms common in glaucoma patients. The study is a single-arm clinical trial where participants will be implanted with the device and monitored. The trial builds on previous device versions and includes refined patient selection and physician training to enhance safety and efficacy. Throughout the 12-month study period, participants will undergo evaluations including applanation tonometry to measure IOP reduction and adverse event monitoring to assess safety. Additional assessments include responder rate and overall safety evaluations. Participants will have follow-up visits to monitor device performance and ocular health. The total study duration extends to primary completion by January 2028 and final completion by March 2029.

Researchers are evaluating Automated Visual Evaluation AVE, specifically the CINFinder version developed by DL Analytics, as a new low-cost, lab-free screening and triage tool for cervical cancer. This study focuses on women in El Salvador, where cervical cancer remains a leading cause of female cancer death due to persistent HPV infection and limited screening resources. The trial compares the sensitivity of AVE against traditional methods like HPV testing and visual inspection with acetic acid VIA. Histopathology diagnosis will be used as the reference standard to confirm disease status. The study involves 10,000 women aged 30 to 59 years undergoing screening visits where HPV samples, VIA, and AVE assessments are performed using the EVA System digital colposcope and an Android smartphone. Women testing positive on any screening test are referred for colposcopy with biopsy, while 5% of screen-negative women also undergo this procedure. Results from the AVE and VIA tests at screening and colposcopy visits will be compared to determine AVEs accuracy as both a screening and triage method. Those diagnosed with precancerous lesions may receive thermal ablation or LEEP treatment according to local standards. Participants will attend up to three visits screening, colposcopy with biopsy, and result delivery with possible treatment. Clinical data, images, and test results are recorded on paper or electronic forms and managed securely with specialized software. The primary outcomes include AVEs sensitivity and positive predictive value for detecting high-grade cervical precancer CIN2 within 12 months. The study includes ongoing follow-up and data verification to assess the new technologys performance in a low-resource setting.