NCT07429110招募中不适用
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
Averto Medical, Inc.11 个研究点 分布在 2 个国家目标入组 250 人开始时间: 2026年6月19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
- 250
- 试验地点
- 11
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.
详细描述
The ColoSeal Intraluminal Colonic Diversion (ICD) System, comprised of the ICD Device and the ICD Device Delivery System, is a minimally invasive medical device designed to temporarily protect a colonic anastomosis from fecal flow. It is initially intended as a less invasive alternative to temporary protective (diverting) ostomy surgery for patients with rectal colon cancer who are undergoing colon resection with reconstruction with an anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 22-75 years of age at screening and is diagnosed with rectal cancer.
- •Subject is determined to be 'robust' as assessed via the Clinical Frailty Scale (CFS; score 1-3), the Mini-Cog (score ≥3) and either the Short Physical Performance Battery (SPPB; score ≥10) or Timed Up and Go (TUG; score <12 seconds). This inclusion applies to subjects aged 71-75 only.
- •Subject is scheduled for elective sphincter sparing resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach).
- •Subject requires the creation of a stapled anastomosis maximally 10 cm from the anal verge, and minimally with sufficient distance from the anal verge to accommodate use of an anastomotic stapler.
- •Subject has been informed of the study's nature, agrees to its provisions, and has provided written informed consent, which has been approved by the appropriate Ethics Committee (EC) or Institutional Review Board (IRB).
- •Subject must have a designated (lay or professional) caregiver available in the in-home setting while the ICD System is in use.
- •Subject should live within ≤ 75 miles (120 km) of their study investigator's facility. If outside of this range, subjects must be willing to stay in accommodations ≤ 75 miles (120 km) of the investigator's facility for 1-day post-study device removal.
- •Subject must be willing and able to comply with protocol requirements, including study follow-up visits.
排除标准
- •Preoperative:
- •Subject at the time of baseline screening is not planned to have ostomy reversal prior to 6 months post-index procedure.
- •Subject with a life expectancy < 1 year due to condition other than rectal cancer.
- •Subject with American Society of Anesthesiologists (ASA) classification >
- •Subject has a systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery.
- •Subject had major surgical or interventional procedure within 30 days before the index procedure or planned major surgical or interventional procedure within 30 days after the index procedure.
- •Subject has received systemic chemotherapy or radiation to the pelvis within 30 days before the planned procedure.
- •Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diffuse descending colon diverticulosis (i.e., diverticula at potential planned fixation site), diverticulitis, or inflammatory bowel disease in the descending colon.
- •Subject has an anatomic abnormality (e.g., polyp, diverticula, vascular malformation) or bowel damage at or within 5 cm of the target device anchor site that could interfere with safe device function.
- •Subject has a diagnosis of coagulopathy (INR≥1.5), thrombocytopenia (platelet count <150,000/μL), or immune suppression (CD4+ T-cell count <500 cells/mm³).
- •Subject has a condition resulting in significant cognitive impairment and/or functional decline, such as dementia or advanced Parkinsons disease.
- •Subject has a BMI ≥
- •Subject is scheduled for a concurrent major surgical procedure during the index procedure (e.g., liver resection).
- •Subject has been taking regular systemic steroid medication in the last 6 months prior to the index procedure.
- •Subject is taking anticoagulants, antimetabolites or antiplatelet agents (Note: low-dose aspirin therapy is permitted) within 7 days of the index procedure.
- •Subject has undergone a prior pelvic anastomosis.
- •Subject has fecal incontinence, involvement of the sphincter by neoplastic disease, or evidence of extensive local disease in the pelvis seen on pre-operative imaging.
- •Subject is diabetic with hemoglobin A1c > 8.0% (64 mmol/mol).
- •Serum albumin of < 3.0 g/dL.
- •Serum prealbumin of <15mg/dL.
- •Subject has a known allergy to any component of the device.
- •Subject has a known allergy to iodine or iodine-based contrast unless the subject can be adequately premedicated before the leak test.
- •Subject has unresolved alcohol or drug abuse, in the investigator's opinion.
- •Subject is pregnant or planning to become pregnant (female subjects of childbearing potential must have a negative urinary pregnancy test ≤ 7 days before the surgical procedure).
- •Subject is unable or unwilling to provide informed consent.
- •Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
- •Intraoperative:
- •Subject is not planned to receive an ostomy placement at the time of the index procedure.
- •Subject's left colon (bowel) preparation on the day of surgery is deemed inadequate for ICD Device placement, as determined by the investigator.
- •Subject requires an end-to-end or side-to-end anastomosis smaller than 31 mm in diameter or greater than 10cm from the anal verge.
- •Subject failed intraoperative leak test.
- •Subject has any condition or abnormality which, in the opinion of the investigator, may jeopardize subject safety or the quality of the study data.
研究组 & 干预措施
Treatment
Experimental
干预措施: ColoSeal ICD System (Device)
Control
Active Comparator
干预措施: Protective Diverting Ostomy (Procedure)
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: 30 days
Freedom from ostomy creation at 30 days.
Primary Safety Endpoint
时间窗: 270 days
The composite rate of subjects with index surgery-related Major Complications for the investigational treatment arm compared to the control arm at 270 days.
次要结局
未报告次要终点
研究者
研究点 (11)
Loading locations...
相似试验
尚未招募
不适用
Diverting Ileostomy and Transverse Colostomy Comparative StudyNCT07283952Assiut University36
招募中
不适用
Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index After Induction of General AnesthesiaNCT07399093Ain Shams University36
终止
不适用
Define Final Selection Choice Criteria for a Coloplast Catheter Ensuring Highest Patient Satisfaction Via Surveys (EVA).Neurogenic Bladder DisorderNon-Neurogenic BladderBladder DysfunctionUrinary RetentionNCT07355803Coloplast NV/SA22
招募中
2 期
A clinical trial investigating Iloprost as medication to improve bone healing in patients with upper arm bone fracture.2024-512468-71-00Charite Universitaetsmedizin Berlin KöR, Charite Universitaetsmedizin Berlin KöR30
Enrolling By Invitation
不适用
Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo DevicesDegenerative Disc DiseaseNCT07370493Centinel Spine200