San Salvador

The trial investigates the use of the Polaris System to assist surgeons in performing cataract surgery in adults aged 40 to 75 with age-related cataracts. This prospective, single-arm, non-randomized study aims to evaluate the safety of this robotic-assisted surgical device, which is designed to improve precision and enhance safety compared to the current standard of care by providing better stability and augmented visualization for surgical decisions. Participants will undergo robot-assisted cataract surgery using the Polaris System. After surgery, they will have four scheduled follow-up visits over a 90-day period to monitor their recovery and safety outcomes. The device is intended to aid in cataract extraction by phacoemulsification with intraocular lens implantation. During the study, participants will be assessed through screening evaluations, surgery, and multiple follow-ups to track safety events over 12 weeks. Researchers will monitor various safety measures, including any adverse events related to the surgery or device. Participants must adhere to prescribed medications and attend follow-up visits to support comprehensive safety monitoring throughout the study duration.

Traumatic brain injury (TBI) is a major cause of death and disability among children worldwide, especially severe TBI in children and adolescents. This trial focuses on whether treatment guided by invasive intracranial pressure (ICP) monitoring improves outcomes compared to treatment based on imaging and clinical exams alone. Conducted in eight Latin American pediatric intensive care units, the study also aims to build research skills among pediatric intensivists in the region and inform global clinical practice for managing severe pediatric TBI. The study compares two management protocols for children aged 1 to 12 years with severe TBI. One group receives care guided by ICP monitoring, while the other group's treatment is based on imaging and clinical assessments without ICP monitoring. Children must be enrolled within 24 hours of injury or deterioration and meet specific neurological criteria. The trial is a randomized controlled design with 428 participants, conducted in hospitals equipped to provide high-quality trauma care. Participants will be followed for at least six months, during which researchers will measure quality of life using the Pediatric Quality of Life Inventory (PedsQL) as the primary outcome. Other assessments include mortality, global outcomes, complications, ICU length of stay, and brain-specific treatments. The study involves close monitoring of neurological status and treatment effects to understand the benefits and risks of ICP monitoring in severe pediatric TBI care.

This research aims to evaluate the safety, usability, and effectiveness of a new accommodating intraocular lens (IOL) called AAL-FAIOL in adults needing cataract surgery in both eyes. The study takes place in Central America and focuses on patients diagnosed with bilateral cataracts requiring lens removal by phacoemulsification, a surgical technique using ultrasound to remove the cloudy lens. The goal is to compare the new AAL-FAIOL lens with the standard BAL-FAIOL lens in the same participants. Participants will undergo cataract surgery in each eye separately, with one eye receiving the AAL-FAIOL and the other the BAL-FAIOL. The eye surgeries will be spaced 14 to 35 days apart. The AAL-FAIOL lens may be adjusted post-surgery using laser energy to improve vision for distance if needed. Both lenses are implantable devices designed for long-term use inside the eye's lens capsule. During the approximately one-year follow-up, participants will attend scheduled visits to monitor eye health and vision. Researchers will assess cumulative eye-related adverse events, including any secondary surgical interventions, from day of surgery up to 12 months. The study will track safety, lens performance, and any adjustments required to optimize vision over the course of the year.

Researchers are evaluating the safety and performance of the SEGER device in adults undergoing elective laparoscopic gastrointestinal surgeries that require intracorporeal anastomosis. This first-in-human feasibility study focuses on procedures like small bowel-small bowel and colorectal anastomoses, aiming to assess the device's safety, technical success, usability during surgery, and early postoperative outcomes. The SEGER device is an investigational surgical tool designed to help close enterotomies and support intracorporeal anastomosis during minimally invasive laparoscopic surgeries. It is used intraoperatively based on the surgeon's judgement as part of the surgical procedure. The study is conducted at a single site in El Salvador and includes patients undergoing procedures such as laparoscopic ileocolic resection, right hemicolectomy, and elective small bowel anastomoses, including some bariatric gastric bypass cases. Participants will be closely followed after surgery to monitor clinical outcomes and recovery. Data collected includes intraoperative details, device performance metrics, early postoperative outcomes, and the incidence of anastomotic leaks within 30 days after surgery. Safety and overall usability of the device during surgery are key measures throughout the study.

Researchers are evaluating an organ dysfunction scoring system adapted specifically for pregnant and early postpartum patients admitted to intensive care units (ICUs). The study aims to develop and validate this obstetric SOFA score (SOFA-OBS) to better predict ICU mortality and sepsis-related mortality in this group. The current general SOFA score does not account for physiological changes during pregnancy and early postpartum, such as reduced creatinine levels and lower blood pressure, which may affect its accuracy in these patients. This study will include about 130 female participants who are either pregnant at any stage or within three days after giving birth and require ICU care. The study will use the new SOFA-OBS score that adjusts kidney and cardiovascular measures to reflect pregnancy changes and simplifies respiratory function evaluation by using a non-invasive pulse oximeter when arterial blood gases are unavailable. The original neurologic, liver, and platelet assessments remain unchanged. Researchers will collect data routinely gathered during ICU care without additional interventions. They will track SOFA and SOFA-OBS scores daily during ICU stays, up to discharge or death, focusing on the first 24 and 48 hours, and assess various organ functions and sepsis definitions adapted to pregnancy stages. Participants will be monitored throughout their ICU stay with data recorded on organ function, infection status, interventions, and outcomes. The study will compare SOFA-OBS with the general SOFA score for predicting mortality and sepsis outcomes. Data collection will include laboratory tests, vital signs, and clinical assessments using standardized forms and electronic systems. Safety and privacy will be maintained, and consent obtained before participation. The total duration depends on ICU stay, with daily evaluations until discharge or death, or up to 28 days post-enrollment for mortality outcomes.

Researchers are evaluating a modified two-probe thermal ablation method using the IRIS™ device along with an AI-based Automated Visual Evaluation (AVE) to improve treatment and diagnosis for HPV-positive women with cervical precancer in El Salvador. The study aims to estimate one-year cure rates of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) after treatment and to assess how well the AVE algorithm identifies women at highest risk compared to traditional biopsy results. The study involves treating eligible women aged 30 to 49 who test positive for HPV with the IRIS™ thermal ablation device. This device uses a short endocervical probe heated to 100°C for 20 seconds followed by overlapping applications of a flat ectocervical probe at the same temperature until the entire affected area is treated. Women not eligible for ablation will receive standard care. A subset of participants will return at 6 weeks and again at 4 to 6 months to monitor safety and treatment effects. Participants will undergo HPV genotyping, colposcopy, biopsy, and endocervical curettage at enrollment and at one-year follow-up. Those with confirmed CIN2+ at baseline will be monitored for persistent disease. Cervical images will be analyzed retrospectively with the AVE algorithm. Safety monitoring, pathology reviews, and data quality assurance will be conducted throughout the study. The primary outcome is the one-year cure rate of CIN2+ after treatment, with additional analysis on the AVE diagnostic accuracy.

Researchers are evaluating a new approach to prevent cervical cancer using a rapid, affordable HPV screening test called the modified AmpFire4. This study focuses on women in Honduras, a low- and middle-income country where cervical cancer is a leading cause of death and current screening coverage is low. The goal is to improve early detection and treatment by combining this test with advanced imaging triage using artificial intelligence (Automated Visual Evaluation, AVE) to reduce overtreatment and increase access to care. The study involves testing 4,000 women using both self-collected and provider-collected samples with the AmpFire4 HPV test, followed by visual inspection, AVE imaging, colposcopy, and biopsy for those testing positive or a subset of negatives. Women who test positive will be offered immediate ablation treatment if eligible. An additional 1,000 women will self-collect samples in a single-visit approach to assess feasibility, with HPV-positive women returning in one year for follow-up testing and evaluation. The study also plans to compare the cost-effectiveness of this new strategy against the current visual inspection method (VIA). Participants will undergo screening visits including consent, questionnaires, and sample collection, followed by diagnostic exams and treatment as needed. Researchers will track test accuracy, patient flow, provider and patient satisfaction, and potential barriers to implementation. Follow-up includes clinical assessments and telephone surveys to monitor side effects. The study will last up to two years and aims to provide data on the performance, feasibility, and economic impact of this innovative cervical cancer screening and treatment approach.

Researchers are evaluating Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, as a low-cost, lab-free screening and triage tool for cervical cancer. This study focuses on women in San Salvador, El Salvador, where cervical cancer remains a leading cause of death due to persistent infection by high-risk human papillomavirus (HPV). The study compares AVE's sensitivity and predictive value against traditional screening methods like HPV tests and visual inspection with acetic acid (VIA). The study involves 10,000 women aged 30 to 59 years and includes a screening visit, a colposcopy visit, and a results delivery and treatment visit. During screening, participants will undergo HPV testing, VIA, and AVE using the EVA System and an Android smartphone for image capture. Women who test positive on any screening test will have a second visit for further HPV genotyping, repeat AVE, and colposcopy with biopsy. A small group of screen-negative women will also have these procedures. Treatment options such as thermal ablation or LEEP will be offered based on histopathology results. Participants will have their medical history recorded, undergo clinical procedures, and have results entered into electronic and paper data systems for accuracy and backup. Cervical images and clinical data will be collected using specialized software. The study measures AVE's sensitivity and positive predictive value over 12 months, using biopsy-confirmed diagnosis as the reference. Women will receive follow-up care including treatment on the same day if eligible, and data management ensures secure and accurate record-keeping throughout the study period.