NCT06915818招募中不适用
GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures
GI Windows, Inc.3 个研究点 分布在 2 个国家目标入组 65 人开始时间: 2025年3月29日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 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 Ileo-colic and Colo-colonic anastomoses in participants undergoing colon 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 Ileo-colic and Colo-colonic anastomoses in participants undergoing colon 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 surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (with anastomosis above the peritoneal reflection) 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
- •All cancer patients must have completed chemotherapy ≥2 months prior to 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 that may suggest difficulty during endoscopic delivery of magnets
- •Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
- •History of recurrent small bowel obstructions.
- •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
- •Congestive heart failure with ejection fraction <35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)
- •Decompensated chronic obstructive lung disease
- •Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
- •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
- •Contraindication to general anesthesia
- •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
Experimental
This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing ileo-colic and colo-colonic anastomosis using the Flexagon SFM Device with OTOLoc.
干预措施: Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and 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
研究者
研究点 (3)
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