NCT07609511招募中不适用
Creation of Magnetic Compression Gastroenterostomy Using the GT Metabolic Solutions Magnet System in Adults With Gastric Outlet Obstruction (GOO): Magnet System GOO Study
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
研究概览
简要总结
Evaluate the performance and safety of the GT Metabolic Magnet System to create side-to-side gastroenteral magnetic compression anastomosis (gastroenterostomy).
详细描述
The purpose of this clinical research study is to evaluate performance and safety of the GT Metabolic Magnet System for creation of a side-to-side gastroenteral anastomosis in adults. The Magnet System is a surgical tool and is intended for use in clinical procedures requiring an anastomosis. Gastroenterostomy for gastric outley obstruction (GOO) is one example of a clinical procedure requiring a gastroenteral anastomosis. Gastroenterostomy is most often created today using incisions and sutures or staples. This study explores creation of a gastroenterostomy with magnetic compression anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric outlet obstruction (GOO) and indicated for a gastroenterostomy, per the discretion of the treating investigator.
- •If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study.
- •Willing and able to comply with protocol requirements and provides written informed consent to participate in the study.
排除标准
- •Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the gastroenterostomy procedure.
- •If GOO due to malignant neoplasm:
- •Baseline Eastern Cooperative Oncology Group (ECOG) > 2 and/or Karnofsky Performance score < 30
- •Gastric or intestinal cancer or malignant infiltration precluding creation of a magnetic compression anastomosis (per investigator discretion)
- •Coagulation disorders, on continuous or complete anticoagulation, or other conditions associated with high risk of bleeding and not correctable or manageable, precluding creation of a magnetic compression anastomosis (per investigator discretion)
- •Any anomaly precluding orogastric access by endoscope and catheters, and manipulation techniques.
- •Implantable pacemaker or defibrillator.
- •Woman who is either pregnant or breast feeding.
- •Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the Magnets.
- •Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnet deployment sites.
- •Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months after the procedure.
- •Any anomaly preventing/contraindicating endoscopic or laparoscopic access and procedures.
- •Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure.
- •Unable to comply with the follow-up schedule and assessments.
- •Known allergies to the device components or contrast media.
- •Currently participating in another clinical research study with an investigational drug or medical device.
- •Any condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 90 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen.
研究组 & 干预措施
Magnet System
Experimental
GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System")
干预措施: Magnet System (Device)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
GT Metabolic Magnet System in Adults With Gastrointestinal DisordersSuperior Mesenteric Artery SyndromeNCT07317076GT Metabolic Solutions, Inc.35
招募中
不适用
Creation of Compression Anastomosis Using the GT Metabolic Magnet SystemNCT07431723GT Metabolic Solutions, Inc.50
招募中
不适用
Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 DiabetesNCT07317115GT Metabolic Solutions, Inc.20
进行中（未招募）
不适用
Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical StimulatorGastroparesisNCT07526935Baylor Research Institute40
招募中
不适用
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional TherapyNCT07350967iIDEAS Group Holdings Limited5