Compression Anastomosis Using the GT Metabolic Magnet System in Adults With Gastrointestinal Disorders (GT Metabolic Magnet System Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Magnet Placement
研究概览
简要总结
Evaluate the performance and safety of the GT Metabolic Magnet System for the creation of side-to-side compression anastomosis in the stomach and/or small bowel in conditions requiring an anastomosis as part of the underlying clinical treatment.
详细描述
Evaluate the performance and safety of the Magnet System as a surgical tool for anastomosis in participants who have partial small bowel obstruction, SMAS, or GOO due to their similarities (they all involve a physical impediment (e.g., compression of the intestinal lumen) and/or mechanical blockage of the GI tract).
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
- •Indicated for gastrointestinal surgery requiring a gastric and/or small bowel anastomosis, without need for immediate lumen patency, and meets one of the following criteria:
- •Superior mesenteric artery syndrome (SMAS); OR
- •Gastric outlet obstruction (GOO); OR
- •Partial small bowel obstruction.
- •Meets the surgical clearance requirements as governed by the investigator's institution.
- •If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study.
排除标准
- •Other gastrointestinal or abdominal surgeries planned concurrently or within the study follow-up period (e.g., bariatric surgery such as sleeve gastrectomy).
- •Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the anastomosis or study procedure, including scarring and abnormal anatomy at the anastomosis sites.
- •Any anomaly precluding gastrointestinal access by gastroscope / endoscope, catheters, and associated manipulation techniques for device placement.
- •Any condition or disease that precludes laparoscopic surgery.
- •Implantable pacemaker, defibrillator, other active and/or metallic implant that may interfere with or be adversely impacted by a temporary magnetic implant (Magnet System) and associated procedures.
- •Unhealed ulcers, bleeding lesions, tumor, diseased tissue or any other lesion at or distal to the target Magnet deployment sites.
- •Any need for immediate lumen patency while the anastomosis is formed.
- •History of prior or current malignancy.
- •Expected need for Magnetic Resonance Imaging (MRI) within the first 3 months post-procedure (or before if Magnet expulsion is confirmed radiologically).
- •Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media.
- •Pregnant, lactating, or planning pregnancy during the clinical investigation and follow up period.
- •Currently participating in an investigational drug, biologic, or medical device or other interventional clinical study.
- •Presence of other anatomic or comorbid conditions, or medical, social or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements.
研究组 & 干预措施
Magnet System
GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System")
干预措施: Magnet System (Device)
结局指标
主要结局
Magnet Placement
时间窗: 1 day
Placement and connection of two intraluminal Magnet.
Natural Magnet Passage
时间窗: 90 days
Successful passage of magnets without surgical reintervention
Anastomosis Patency
时间窗: 90 days
Creation of a patent anastomosis confirmed radiologically.
次要结局
未报告次要终点