NCT07431723招募中不适用
Creation of Compression Anastomosis Using the GT Metabolic Magnet System as Either the Primary or the First Stage of Colorectal Surgery (MagCR Study)
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Magnet Placement
研究概览
简要总结
Evaluate the performance and safety of the Magnet System to create anastomoses throughout the large bowel and between the large and distal small bowel.
详细描述
The objective of the MagCR Study is to evaluate the performance and safety of the Magnet System in eligible participants with colorectal disease as either primary or the first stage of surgical treatment. A magnetic compression anastomosis is fully reversable and may be considered for temporary staging of surgical treatments. Reversal of the compression anastomosis may be easily performed given the Magnet System leaves no foreign material behind (e.g., sutures or staples).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indicated for colorectal surgery requiring anastomosis within the colon or colon and distal small bowel (i.e., colocolic, colorectal, rectalrectal, ileocolic, or ileorectal) performed side-to-side or endto-end with ileostomy
- •Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent.
排除标准
- •High frailty index, with a score of ≥ 3 on the five-item modified frailty index (mFI-5).
- •Severe Sarcopenia as determined by the investigator.
- •Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy at the target anastomosis sites.
- •Any anomaly precluding orogastric access by colonoscope and catheters, and manipulation techniques.
- •Any anomaly preventing / contraindicating colonoscopic or laparoscopic access and procedures.
- •Implantable pacemaker or defibrillator (and/or other devices that may be impacted by or interfere with the Magnet System).
- •Psychiatric disorder, except well-controlled depression with medication for > 6 months.
- •Pregnant, lactating, or planning pregnancy during the clinical investigation.
- •Any comorbidity or current status of participant's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the participant 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 site.
- •Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure.
- •Any surgical or interventional procedure (including planned and/or scheduled) within the period of 30 days prior to and 30 days following the study procedure.
- •Any stroke/Transient Ischemic Attack (TIA) ≤ 6 months prior to consent.
- •Requires chronic anticoagulation therapy (except aspirin).
- •Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure.
- •Current tobacco / nicotine product usage or recent product cessation ≤ 3 months prior to informed consent.
- •Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media.
- •Participants with comorbidities that are likely to result in a life expectancy ≤ 12 months.
- •Currently participating in an investigational drug or another device study that has not reached its primary endpoint
- •Presence of other anatomic or comorbid conditions, or other 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, or impact the scientific soundness of the clinical investigation results.
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)
结局指标
主要结局
Magnet Placement
时间窗: 1 day
Successful placement and connection of the Magnets
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
研究者
研究点 (2)
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