Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections

A regiszterben nem jelölt feltételek

• Preoperative Inclusion Criteria:
• Subject is competent and willing to provide documented informed consent to participate in this clinical study
• Subject is intended to undergo an elective left sided colon/colorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler
• Subject is ≥ 18 years of age at time of consent
  • Preoperative Exclusion Criteria:
• Subject is unable or unwilling to comply with the study requirements or follow-up schedule
• Subject with ASA classification ≥ IV
• Subject is pregnant (as determined by standard site practices)
• The procedure is an emergency procedure
• The procedure is a revision/reoperation for the same indication
• The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months
• Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study
• Subject will undergo multiple synchronous colon resections
• Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)
• Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure
• Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)
• Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)
• Any subject undergoing an ileal-anal pouch anastomosis surgery
  • Intraoperative Exclusion Criteria
• Anastomosis not attempted with the Signia™ circular stapler
• Any subject for which the device is intended to be used outside the instructions for use (IFU)