Ensayos clínicos

Inclusion Criteria:

• Be at least 22 years of age
• Be scheduled for a colorectal or ileorectal anastomosis procedure with a diverting stoma
• Agree to return for all follow-up evaluations and procedures specified in the protocol Understand and give informed consent

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study;

• Albumin < 3 g/dL
• ASA score (American Society of Anesthesiologists) ≥ 4
• Neutropenia ≤ 800 cells/µl
• Pregnancy
• The following conditions involving compromised immune system: AIDS (HIV positive not excluded), neutropenia
• Known blood clotting disorder requiring treatment
• Have known or suspected allergy or sensitivity to any test materials or reagents
• Concurrent use of fibrin sealants or other anastomosis care devices
• Surgery for emergency abdominal indications
• Patients who have undergone prior colorectal anastomosis surgery in the previous two months, or are receiving an additional anastomosis related to complications from a previous anastomosis procedure
• Stage 1 (First 20 patients) Only (High Risk Cancer Patients (as determined by preoperative clinical evidence or diagnostic imaging) (If patient's cancer stage has been downstaged through treatment prior to baseline screening, subject is allowed to be included.):
  • Lymph Node Cancer Stage: N2
  • Cancer Tumor Size: T4
  • Circumferential resection margin: CRM+ (Positive)