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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the performance and safety of the GT Metabolic Magnet System, a device designed to create side-to-side compression anastomosis in the stomach and/or small bowel. This study focuses on adults with gastrointestinal conditions requiring an anastomosis, specifically those with partial small bowel obstruction, superior mesenteric artery syndrome (SMAS), or gastric outlet obstruction (GOO). These conditions share common features involving physical or mechanical blockage of the gastrointestinal tract. The study uses the Magnet System to perform magnetic compression anastomoses as a surgical tool for intestinal diversion. Participants receive this device-based treatment aimed at creating the necessary anastomosis without immediate lumen patency. The procedure involves placing magnets that compress the tissue to form the connection, and the study monitors the magnet placement and natural passage over time. Participants will be followed to assess outcomes including magnet placement after one day, natural magnet passage, and anastomosis patency over 90 days. The study involves regular assessments to monitor the safety and functionality of the anastomosis, with investigators tracking the healing process and any complications. The overall goal is to understand how well the device works and its safety profile in these specific gastrointestinal disorders.
Actively Recruiting
Healthy Volunteer
Soft tissue filler injections are increasingly popular for facial rejuvenation, including restoring volume and enhancing contour. This research aims to understand how two types of hyaluronic acid (HA)-based fillers—Non-Animal Stabilized Hyaluronic Acid (NASHA) and Optimal Balance Technology (OBT)—behave in the face after injection. The study focuses on comparing their patterns of integration into tissue and evaluating if either filler tends to move away from the injection site over time. Participants will receive treatments in at least two different facial areas, one with a Restylane NASHA product and another with a Restylane OBT product. The study includes three scheduled MRI scans to monitor the fillers at baseline (after optimal correction), 12 weeks, and 24 weeks. These scans will help visualize and assess the presence or movement of fillers within the facial tissues. Throughout the study, participants will attend follow-up visits for MRI scans and assessments. Researchers will track the distribution and integration of the fillers, looking closely for any evidence of filler migration from the original injection sites. Participants must refrain from other facial procedures during the study and will be monitored for safety and compliance. The total study duration includes baseline and visits up to 24 weeks after treatment.
Actively Recruiting
Researchers are evaluating the performance and safety of the MagDI System in adults aged 18 to 65 who need a duodeno-ileal side-to-side anastomosis procedure for partial intestinal diversion. This procedure is studied as a method to support weight management and improve metabolic outcomes, especially in obese adults with or without type 2 diabetes. The study also aims to assess the initial effectiveness of this duodeno-ileal diversion using the MagDI System. Side-to-side anastomosis is commonly performed using staples or sutures, but this study evaluates a new magnetic compression device as an alternative. Participants will undergo the duodeno-ileal diversion procedure using the MagDI System, which achieves anastomosis through magnetic compression. The study focuses on a specific type of side-to-side duodeno-ileostomy procedure, designed to help with obesity and metabolic conditions. The procedure involves creating a partial diversion of intestinal contents from the duodenum to the ileum. The study assesses the device's performance for 90 days after the procedure and monitors safety for up to 360 days. During the study, participants will be closely monitored with follow-up visits, required testing, and evaluations to assess the device's function and safety outcomes. Researchers will track the performance of the magnetic anastomosis as well as any adverse events throughout the study period. Participants are expected to comply with study visits and procedures, including safety monitoring for one year after the procedure to evaluate the long-term safety of the MagDI System.
Actively Recruiting
Researchers are evaluating the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable (MagGJ System), to create a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults. This partial diversion of intestinal contents from the stomach to the ileum or jejunum aims to support weight management and metabolic improvements, especially in adults with type 2 diabetes. The study compares this magnetic compression approach to existing surgical procedures like the single anastomosis sleeve ileal (SASI) bypass and one anastomosis gastric bypass (OAGB). The study uses the MagGJ System device to achieve anastomoses by magnetic compression. The procedure involves creating a side-to-side connection between the stomach and the ileum or jejunum to divert intestinal contents. This approach is intended either as a first stage for a two-stage gastric bypass or as a treatment for weight regain after previous sleeve gastrectomy. Participants receive the magnetic device placement and are monitored for the device's passage and anastomosis patency over 30 days. Participants will undergo assessments including magnet placement verification after one day, monitoring natural magnet passage within 30 days, and evaluation of anastomosis openness at day 30. The study includes follow-up visits for safety and effectiveness, with a total participation duration of up to one year. Researchers will observe metabolic outcomes, weight changes, and any adverse events during this period to evaluate the device's feasibility and safety.
Actively Recruiting
Researchers are evaluating the functional improvement of type 2 diabetes (T2D) in adults with obesity and T2D by comparing two treatments: a surgical approach using the Magnet System for side-to-side duodeno-ileostomy and a medication approach using semaglutide. Participants must have a body mass index (BMI) between 30 and 40 kg/m2 and an HbA1c level of 6.5% or higher to be eligible for this study. The study aims to assess how each treatment improves diabetes control by measuring changes in HbA1c over one year. The study involves two treatment groups. One group will undergo surgery with the Magnet System, which uses magnetic compression to create a side-to-side connection between the duodenum and ileum for intestinal diversion. The other group will receive weekly subcutaneous injections of semaglutide, a glucagon-like peptide-1 receptor agonist, with doses up to 2.4 mg or adjusted based on tolerance and side effects. Participants will not undergo additional metabolic or bariatric surgery or take other similar diabetes medications during the study period. Participants will be monitored for one year, with the primary outcome being the improvement in HbA1c levels at day 360. The study includes assessments to ensure safety and adherence to treatment, with researchers checking for any medical or social conditions that could affect participation or treatment compliance. Participants must provide informed consent and agree to follow study requirements, including randomization and follow-up visits.