Endoscopy

This observational study focuses on children under 18 years of age with tracheostomies who are followed at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Sweden. It aims to determine how often tracheostomy-related airway complications are asymptomatic or linked to symptoms detected through surveillance airway endoscopy. Additionally, the study evaluates how accurately caregivers and pediatricians can identify symptoms related to serious airway complications. Children scheduled for regular surveillance airway endoscopy under anesthesia as part of their follow-up at LIVA will be included. Upon admission, caregivers complete a questionnaire about possible symptoms of airway complications. The child then undergoes a physical exam and medical history review by a pediatrician following a set protocol. An ENT surgeon, unaware of the questionnaire and pediatrician exam results, performs the airway endoscopy to identify complications. During the study, researchers will compare caregiver and pediatrician reports with findings from airway endoscopy to assess symptom reliability. The main measurements include the proportion of patients with serious tracheostomy airway complications who show no symptoms before endoscopy. The study spans two years, with ongoing surveillance and the collection of data on symptoms and complications. Ethical approval has been obtained to conduct this research.

Many premature newborns have trouble breathing after birth and receive support with a breathing machine called nasal continuous positive airway pressure (NCPAP). When their breathing worsens despite NCPAP, they may be treated with surfactant medication inserted into the windpipe using either a ventilation tube or a thin catheter. This research is studying the use of video laryngoscopes, which have a camera and display the airway on a screen, compared to standard direct laryngoscopes that require doctors to look directly into the baby's mouth to insert the tube or catheter. The study aims to see if video laryngoscopy improves the success rate of inserting the thin catheter on the first attempt without causing drops in oxygen or heart rate. The study observes infants who need a thin endotracheal catheter inserted for surfactant administration. It compares two approaches: using a video laryngoscope versus a direct laryngoscope during the insertion. This is done across multiple hospitals, each switching from direct to video laryngoscopy over time. The study does not assign which method is used but records which laryngoscope was used for each insertion attempt to compare outcomes. The main focus is on successful first attempts without physiologic instability, as well as secondary measures like number of attempts, duration, oxygen levels, heart rate, and any complications. Participants are newborn infants up to 28 days old who require thin catheter insertion for surfactant treatment and whose parents have consented to share data. Researchers will collect detailed information during and after the insertion attempt, including heart rate, oxygen saturation, duration of the procedure, and any adverse events such as oral trauma or need for chest compressions. Data will be analyzed to evaluate the success and safety of using video versus direct laryngoscopy. The total participation time depends on when the catheter insertion is performed and the follow-up assessments within 72 hours after the procedure.

Many newborn babies experience breathing difficulties that require intubation, a procedure where a tube is inserted into the windpipe to help with breathing support. This trial compares two methods used by doctors to perform intubation: the traditional direct laryngoscopy (DL), where doctors look directly into the baby's mouth with a standard laryngoscope, and video laryngoscopy (VL), which uses a camera and screen to view the windpipe. The study aims to determine if VL leads to more successful first attempts without causing drops in oxygen levels or heart rate compared to DL. The trial uses a stepped-wedge cluster randomized design across multiple hospitals. Initially, each hospital uses the standard DL method for intubation. At randomly assigned intervals, hospitals switch to using the VL device, the C-MAC video laryngoscope, which includes a monitor and special blades. Doctors receive training and practice with this device before switching. Other intubation practices, such as drug use and supplemental oxygen, remain the same throughout the study. Participants in the trial are newborn infants undergoing intubation. Researchers will collect information about intubation attempts, including success rates, oxygen levels, heart rates, and any complications like oral trauma or need for chest compressions. The main outcome is whether babies are successfully intubated on the first try without physiological instability within five minutes. Additional measures include procedure time, number of attempts, and adverse events. Data will be compared between the periods using DL and VL to assess effectiveness and safety over the course of the study, which lasts until August 2026.

This research aims to evaluate Bevonescein, a sterile intravenous drug, in patients undergoing minimally invasive abdominopelvic surgery. The study focuses on assessing the safety, tolerability, and effectiveness of Bevonescein in highlighting nerves and ureters during surgery. It also investigates how the drug behaves in the body and the dose needed to produce clear fluorescent imaging for nerve and ureter visualization. Participants will receive Bevonescein during two study phases: a dose defining phase and a dose expansion phase for each surgical setting. The drug is given as an intravenous infusion, and the study uses specialized imaging systems to record fluorescence signals in targeted tissues. These phases help determine the optimal dose and gather safety and imaging data. Throughout the study, participants will be monitored with fluorescence system surveys approximately 28 days after dosing, plus or minus 5 days. Researchers will collect data on the drug's imaging effects and safety. The total duration includes screening, dosing, and follow-up assessments to evaluate Bevonescein’s performance during minimally invasive surgery.

This research is focused on adults aged 18 years and older who have kidney or ureteral stones and are undergoing ureteroscopy with stent placement. The study aims to find out whether adding the corticosteroid prednisone to the usual pain medications after surgery can help reduce postoperative pain. It is a Phase 4 trial sponsored by Mayo Clinic, involving people of all genders and ethnic backgrounds. Participants are randomly assigned to one of two groups. One group receives the standard postoperative ureteroscopy medication plus prednisone 25 mg taken orally once daily for five days after surgery. The other group receives the same standard care plus a placebo pill with the same schedule. This triple-blind study compares the effects of prednisone versus placebo in managing post-surgical pain. During the study, pain levels will be measured using the Visual Analog Scale at baseline and on days 1, 2, and 3 after surgery. Researchers will also track the use and amount of non-opioid pain medications over three days, as well as changes in quality of life and stent symptom scores. The study includes careful monitoring of participant adherence and safety throughout the postoperative period, with total participation spanning at least the first three days after surgery.

Researchers are evaluating the feasibility and safety of an artificial intelligence (AI)-driven autonomous registration technology in robotic navigational bronchoscopy for patients with pulmonary nodules needing localization. The study will enroll 20 patients to assess how well this AI system aligns pre-operative chest CT images with real-time bronchoscopic anatomy, aiming to reduce the need for manual registration by physicians. The main goals include measuring the success of the AI registration and how often manual help is needed during the process. All participants will undergo robotic navigational bronchoscopy and nodule localization using the Langhe Bronchoscopy Robot System equipped with the AI-based autonomous registration software. Physicians will oversee the procedure and intervene manually if the AI registration does not meet safety or quality standards. This approach focuses on improving the registration process before the bronchoscopic procedure begins. Participants will be closely monitored during and after the procedure with assessments of registration success, time used for registration, any complications within 24 hours, and success in localizing nodules. The study involves collecting data during the operation and immediately afterward to evaluate the AI system's performance and safety. Total study participation includes the procedure and short-term follow-up to check for complications and outcomes.

Researchers are evaluating a new noninvasive system that uses artificial intelligence (AI) to analyze multiple types of imaging, including magnetic resonance enterography (MRE) and computed tomography enterography (CTE), to help diagnose and predict outcomes for digestive diseases. This observational study collects and analyzes retrospective imaging, endoscopic, and clinical data from 21 centers in China to build and improve the AI model. The model will then be tested prospectively in two centers and its ability to locate lesions will be checked in real-world endoscopy settings. The study involves using a virtual endoscopy model to assist in diagnosis by integrating and analyzing multimodal imaging features. The AI system is designed to support diagnosis without any invasive procedures. The study will confirm the model's accuracy and effectiveness through retrospective data, prospective validation, and real-world deployment in clinical environments. Participants will contribute data from their imaging and endoscopic exams, with at least one technically adequate CT or MR scan and a high-quality colonoscopy performed within one month of imaging. Researchers will assess the AI model's diagnostic performance by measuring the area under the ROC curve (AUC) over six months. The study includes ongoing monitoring of data quality and imaging accuracy to ensure reliable validation of the AI system.

Researchers are studying how to best monitor sedation and pain response during painless gastrointestinal endoscopy using a new medical device that measures brain activity. This device records two indices, the quantitative consciousness (qCON) and quantitative nociceptive (qNOX), which may reflect sedation depth and pain signals. The study aims to combine these measurements with visual and physiological monitoring to find the optimal sedation level during gastroscopy and colonoscopy procedures. This single-center, prospective observational study involves 220 patients, evenly split between gastroscopy and colonoscopy groups. Patients receive anesthesia induction with propofol and sufentanil, monitored by an EEG bispectral index device (Apollo-9000A) to track qCON and qNOX values. The sedation is adjusted to keep patients at a low alertness level with no body movements during the procedures. Clinical signs like cough reflex and vital signs are also recorded. Participants will be observed throughout the procedure with measurements of qCON, qNOX, blood pressure, heart rate, oxygen saturation, and sedation scores. Adverse events during and up to 24 hours after the procedure will be documented. The main outcome is anesthesia quality during the procedure, with secondary outcomes including changes in monitoring indices and safety measures. The total study period covers the procedure and 24-hour follow-up for complications.

Researchers are evaluating the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy (TBLC) in people with progressive pulmonary fibrosis. The study aims to understand patient prognosis, health economic impacts, and how therapeutic strategies may change following TBLC. Participants diagnosed with progressive pulmonary fibrosis will be randomly divided into two groups to receive either transbronchial lung biopsy (TBLB) or TBLC. The study compares two procedures: transbronchial cryobiopsy, a newer technique used to diagnose various diffuse lung diseases, and transbronchial lung biopsy, a more commonly used and relatively safe diagnostic method. These procedures will be performed to assess their diagnostic value and safety in this patient population. Participants are assigned randomly to one of these two biopsy methods. During the study, participants will be monitored for diagnostic performance one month after biopsy. Safety assessments will be conducted at seven days and one month after the procedure. Researchers will collect data on lung function, imaging, and clinical status to evaluate outcomes. The study will continue until the end of 2026, with detailed follow-up to measure the impact of each biopsy technique on diagnosis and patient care.

This research aims to evaluate an artificial intelligence (AI) system designed to automatically assess the extent of gastric intestinal metaplasia (GIM) during endoscopy by calculating the EGGIM scores. Gastric intestinal metaplasia is an important precancerous condition, and the study seeks to validate the accuracy, performance, and reliability of this AI-assisted scoring method in a prospective, multi-center setting. Participants will undergo an image-enhanced endoscopy (IEE) examination, where both experienced endoscopists and the AI system independently assess the extent of GIM using the EGGIM score. This study builds on prior preliminary research and aims to confirm the AI system's diagnostic performance compared to human experts. During the study, patients aged 40 to 75 years who consent to participate will have their endoscopic images evaluated by both the AI and the endoscopists. The main outcome measured is how well the AI system diagnoses the grade of intestinal metaplasia by calculating the EGGIM score within one year. This observational study involves no experimental treatments, focusing on diagnostic evaluation and data collection over the study period.