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A Safety and Effectiveness Prospective Blinded clinical study to validate xBar system as monitoring tool for anastomotic leaks detection

Clinical Trial Details

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. 

Key Eligibility: 

Inclusion Criteria:

  1. Over the age of 22
  2. Indication for sigmoid or rectal resection surgery.
  3. Usage of drain during the surgery (to be confirmed during the surgery)

Exclusion Criteria:

  1. Pregnancy or lactation.
  2. Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
  3. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
  4. Participation in another interventional study during the xBar system usage.

Detailed eligibility will be discussed with the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Rohit Rasane
646-962-2789
rkr4004@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2403027201

ClinicalTrials.gov:

NCT06168669

Sponsor:

CLP 03

Status

Open to Enrollment

Age Group

Adult

Sponsor