A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Proce… (NCT04247958) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Single-Center Evaluation of SureFormâ„¢ Staplers in Robotic-assisted Colorectal Procedures
United States60 participantsStarted 2020-01-30
Plain-language summary
The primary objective of this study is to evaluate the performance of SureFormâ„¢ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* The subject must be 18 years of age or older at the time of consent
* Subject undergoing robotic-assisted colorectal procedure for benign or malignant colon or rectal disease, where SureFormâ„¢Staplers are utilized for transection and/or creation of anastomosis
Exclusion Criteria:
* Subject has had prior neoadjuvant (chemotherapy and/or radiation) therapy
* Subject with active bacterial or fungal infection
* Subject is contraindicated for general anesthesia or surgery
* Subject is undergoing an emergency procedure
* Subject has other major concomitant procedures (e.g. hepatectomies, incisional ventral hernia repair, nephrectomies, hysterectomy) planned along with colorectal procedure.
* Subject has metastatic disease and/or subject has life expectancy of less than 1 year
* Subject is under an immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgical procedure
* Subject has history of coagulation or hematologic disorder
* Pregnant or suspect pregnancy
* The subject is unable to comply with the follow-up visit schedule
* Subject has perforated, obstructing or locally invasive neoplasm (T4b)
* Subject with inflammatory bowel disease
* Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
* Subject belonging to other vulnerable population, e.g, priso…
What they're measuring
1
Number of SureFormâ„¢ Stapler fires and reload colors