GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Gastric-Jejunal Anastomoses in Patients Undergoing Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
研究概览
简要总结
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a gastro-jejunal anastomosis in participants undergoing gastric surgery.
详细描述
This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating gastric-jejunal anastomoses in patients undergoing gastric surgery.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 22 years or older at screening
- •Candidate for gastric surgery requiring gastro-jejunal or gastro-ileal anastomosis with cardiac/medical clearance for surgery
- •Able to understand and sign informed consent document
- •American Society of Anesthesiologists (ASA) score < IV at time of procedure
- •Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study
- •Able to refrain from smoking during study follow-up period
排除标准
- •Known or suspected allergy to silicone, nickel, titanium or Nitinol
- •BMI > 55 kg/m2
- •Uncontrolled diabetes (defined as HbA1c >10%)
- •Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
- •Diagnosed with obstructed or perforated colon cancer
- •Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
- •Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
- •Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL
- •Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysis
- •Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
- •Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
- •Active H. pylori infection Participants with active H. pylori may continue with the screening process if they are treated via medication
- •Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
- •Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician
- •Contraindication to general anesthesia
- •Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
- •Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
- •Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
研究组 & 干预措施
Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc
This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing gastric-jejunal anastomosis using the Flexagon SFM Device with OTOLoc.
干预措施: Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc (Device)
结局指标
主要结局
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
时间窗: 30 Days
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.
次要结局
未报告次要终点