Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cohera Medical, Inc.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Be 22 years of age or older
Be scheduled for a colectomy procedure with a stapled anastomosis
At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (≥90%)
Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak
Agree to return for all follow-up evaluations and procedures specified in the protocol
Understand and give informed consent
You may not be if
Albumin \< 3 g/dL
ASA score (American Society of Anesthesiologists) ≥ 4
Neutropenia ≤ 800 cells/µl
Pregnant at time of surgery
Has AIDS (HIV positive not excluded)
Has neutropenia (IBD and steroid use not excluded)
Has a known blood clotting disorder requiring treatment
Has any condition known to effect wound healing, such as collagen vascular disease
Has known or suspected allergy or sensitivity to any test materials, reagents, or WCE contrast materials
Has undergone chemotherapy within 4 weeks of the anastomosis procedure and/or radiation within 3 days of the anastomosis procedure
Concurrently using fibrin sealants or other anastomosis care devices
Emergency surgery for abdominal indications
Has undergone a colectomy procedure in the previous two months
Has an emergent infection related to a previous colectomy procedure
Is scheduled to undergo a Hartmann's procedure
Is scheduled to undergo trans-anal endoscopic microsurgery (TEM)
Is scheduled to undergo procedure using omental wrapping
Is participating in another medical device trial involving colectomy with anastomosis
First 20 subjects ONLY:
Is diagnosed with high risk cancer 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):
