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Metabolic dysfunction-associated steatotic liver disease (MASLD), previously called non-alcoholic fatty liver disease (NAFLD), is a common liver condition linked to obesity, diabetes, and cholesterol problems. It ranges from simple fat buildup in the liver to more severe states like metabolic dysfunction-associated steatohepatitis (MASH), liver fibrosis, cirrhosis, or liver cancer. Patients with MASH also face higher risks of heart disease and death. Currently, no medication is universally approved for MASH, and weight loss remains the main treatment approach. This research aims to compare the effects of metabolic surgery versus incretin-based drug therapies on liver health in patients with obesity and biopsy-confirmed MASH and liver fibrosis. Participants will be randomly assigned to one of two groups: metabolic surgery or medical treatment with incretin-based therapies such as liraglutide, semaglutide, or tirzepatide. The surgical group will undergo either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG), with the choice made by the patient and medical team based on health factors and preferences. The medication group will receive approved incretin drugs in various forms and doses, tailored to availability and clinical needs. The study will last for two years, during which patients will be monitored and will have liver biopsies before starting and at the end of the study to assess changes in liver fibrosis. Throughout the trial, about 120 adult participants with obesity and MASH will be closely followed. They will undergo liver biopsies at the start and after two years to measure fibrosis improvement using the Kleiner fibrosis classification. Researchers will also monitor weight, medication adherence, and other health indicators. Safety and treatment effects will be evaluated over the two-year period. The study is conducted at multiple centers internationally, with the main site at Cleveland Clinic in the USA.

This research aims to evaluate the long-term weight loss outcomes of patients who underwent an Endoscopic Sleeve Gastroplasty (ESG) procedure at least five years before joining the study. The focus is on understanding the sustained weight loss journey and the effectiveness of ESG for managing obesity and related medical conditions over an extended period. Participants in this study have previously received the ESG procedure using the Overstitch Endoscopic Suturing System and have completed follow-up visits for weight loss management at one year and annually between two and four years after the procedure. The study involves no new interventions but includes retrospective data collection and one prospective visit at five or more years after the ESG procedure. During the study, participants will complete one prospective visit, during which researchers will assess the proportion of individuals who maintain clinically significant weight loss five years after the ESG procedure. The study includes reviewing follow-up data collected over several years to understand long-term weight loss maintenance. Participants must be able to read, understand, and sign consent forms to participate.

Researchers are evaluating the safety and effectiveness of the Flexagon Self Forming Magnet (SFM) system combined with the OTOLoc device to create ileo-colic and colo-colonic anastomoses in patients undergoing colon surgery. This prospective, multi-center, single-arm clinical study focuses on participants requiring colon surgery such as Right Hemicolectomy or Sigmoid/Low Anterior resection. The study involves delivering Flexagon SFMs and OTOLoc devices laparoscopically and/or endoscopically into the ileum or colon where the anastomosis is intended. The OTOLoc device is deployed into the bowel wall to facilitate placement of the Flexagon SFM, which are then coupled together to form the anastomosis. This method allows fluid communication between the two lumens until the anastomosis fully forms. Participants will be monitored for the success of anastomosis creation without needing reoperation within 30 days. Assessments include surgical outcomes, safety monitoring, and follow-up visits. The study requires participants to stay within proximity of the study center and to refrain from smoking during follow-up. The overall participation duration and detailed safety evaluations are part of the study protocol to ensure comprehensive data collection.

Researchers are evaluating the safety and effectiveness of the Flexagon Self Forming Magnet (SFM) system combined with the OTOLoc device to create a gastro-jejunal anastomosis in patients undergoing gastric surgery. This prospective, multi-center, single-arm clinical study focuses on patients needing gastric surgery that requires creating a connection between the stomach and jejunum. The goal is to assess how well this device system works and whether it can avoid the need for additional surgery within 30 days after the procedure. The study investigates one intervention where the Flexagon SFM and OTOLoc devices are delivered laparoscopically and/or endoscopically into targeted areas of the stomach and jejunum. The OTOLoc device is first placed on the gastric wall to help deploy the Flexagon SFM into the stomach. The same process is repeated on the jejunum. Then, the magnets are aligned and connected, forming the anastomosis while allowing fluid communication between the two sections until the connection is fully established. Participants will undergo the surgical procedure and have close follow-up to monitor the success of the anastomosis and any need for reoperation within 30 days. Researchers will collect data on the procedure's safety and effectiveness during this period. Patients must be able to remain near the study center for the study's duration and comply with study requirements such as refraining from smoking during follow-up. The total participation time depends on the follow-up period after surgery.

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction (MI), including both ST-segment elevation MI (STEMI) and non-ST-segment elevation MI (NSTEMI), who also have multivessel coronary artery disease (CAD). The trial compares physiology-guided revascularization, which uses specific measurements to decide treatment, with angiography-guided revascularization, which relies on imaging. The study aims to determine if the physiology-guided approach is not worse than the angiography-guided method in preventing cardiovascular death, new MI, or ischemia-driven revascularization, and whether it is better at reducing safety issues like bleeding, stroke, or kidney injury. Participants undergo procedures to treat non-culprit lesions (NCLs) using either physiology guidance or angiography guidance. In the physiology-guided group, percutaneous coronary intervention (PCI) is performed on lesions with resting full-cycle ratio (RFR) of 0.89 or less or fractional flow reserve (FFR) of 0.80 or less, according to local practice. The angiography-guided group receives PCI based on imaging assessments following local practice. The study includes an observational imaging sub-study using optical coherence tomography (OCT) for a subset of patients. Participants are involved for a minimum of two years, during which researchers monitor the time to first cardiovascular events such as death, new MI, or additional revascularization, along with safety events like bleeding or stroke. The study includes regular evaluations and follow-up to assess these outcomes, ensuring comprehensive safety and efficacy data collection in this patient population.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

Chronic kidney disease (CKD) affects over 800 million people worldwide and is expected to become the 5th leading cause of death by 2040. CKD progresses to kidney failure, increases risks of early death and heart disease, and reduces quality of life. Current treatments do not fully prevent kidney failure, so this trial aims to find the best treatment or combination of treatments to slow CKD progression. CAPTIVATE is a Phase III, international, multi-center, adaptive platform trial designed to answer multiple treatment questions efficiently within a single research framework. Participants receive study treatments, such as Finerenone or placebo tablets taken orally once daily, for two years. They may be involved in more than one treatment at the same time or at different times. Follow-up visits occur around 1 month, 3 months, 6 months, 12 months, 18 months, and 2 years after starting treatment, with a final visit one month after treatment ends. The trial is ongoing and flexible, allowing new treatments to be added or removed based on results. During the study, participants have blood and urine tests, safety assessments, and treatment adherence monitoring. Health information is collected at study visits and every five years to evaluate long-term outcomes. The main measurement is the change in kidney function (eGFR slope) from the start of treatment to week 108. The study continues recruiting participants for many years to improve CKD treatment options.