Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT04247958
Eligibility Criteria:
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 SureForm™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, prisoner or ward of the state
Intra-Operative Exclusion Criteria:
* Subjects who require extensive dissection to release adhesions or with advanced cancer which may result in anastomotic leak and/or bleeding unrelated to the stapler.
* Inadequate visualization making an endoscopic approach not feasible
* Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04247958
Study Brief:
Protocol Section:
NCT04247958