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xBar is an investigational device intended for post-op monitoring of patients undergoing gastrointestinal (GI) surgery. The device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. The collected data is processed for early detection of complications.
Investigational means that xBar has not been approved by the U.S. Food and Drug Administration (FDA).
The study is intended to validate the performance of the xBar system's anastomotic leak detection monitoring tool following colorectal resection with drain placement. During the index surgery the xBar device will be placed according to institution standard procedures and data recording will commence for a period of at least 3 days. Safety and complication detection performance will be evaluated retrospectively by comparing the diagnosis on a participant level done by the clinical team, who is blinded to xBar results, and the system.
The research team (the doctor and research staff) will place the xBar drain during surgery, just like they would place any other marketed surgical drain intended to be used in the surgery.
Participants will be contacted at 30 and 90 days after the surgery by the clinical team to inquire about participant wellbeing. The surgeon will decide when the xBar should be removed. The removal procedure of the xBar is similar to any other drain removal procedure.
Inclusion Criteria:
Exclusion Criteria:
Detailed eligibility will be discussed with the study team.