A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures

Completed

Conditions studied: Benign Colon Tumor, Malignant Colorectal Tumor, Benign Colorectal Neoplasm

In brief

The primary objective of this study is to evaluate the performance of SureForm™ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.

Key facts

Study ID

NCT04247958

Run by

Intuitive Surgical

People needed

60

Starts

2020-01-30

Expected to finish

2023-12-31

Last updated by the study team

2024-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oklahoma Surgical Hospital — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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