SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study

Laborértékek

• Preoperative:
  • Active colitis
  • Known allergy to nickel or other components of the Colovac system
  • Pregnant or nursing female subject
  • Concomitant major surgical procedure in combination with Colorectal resection (i.e., hepatectomy)
  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo protocol-described procedures or interfere with the interpretation of study results including, but not limited to:
  • Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
  • Immunodeficiency (CD4+ count < 500 CU MM)
  • Systemic and ongoing steroid therapy within the past 6 months
  • Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
  • Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
  • Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, or carcinomatosis
  • Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
  • Severe malnutrition defined as 10% weight loss within 3 months prior to enrollment.
  • The subject is currently participating in another investigational drug or device study that may confound the results of SAFE-3CV. Prior approval from SafeHeal Medical Monitor must be obtained prior to enrollment in SAFE-3CV.
  • Intraoperatively:
  • Occurrence of any of the following during the colorectal surgery:
  • Blood loss (>750 cc)
  • Blood transfusion
  • Any new sign of bowel ischemia
  • Positive air leak test
  • Inadequate bowel preparation
  • Anastomosis location greater than 10 cm from the anal verge
  • Any other surgical complications or intra-operative risks that may place the patient at greater risk from study procedures

• A subject meeting all of the following criteria will be considered for participation in the study:
• Adult patients (22 years of age or older)
• Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form