Clinical Trials

Inclusion Criteria:

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.

Exclusion Criteria

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)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/1/2025. Questions regarding updates should be directed to the study team contact.