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

NCT04247958 | Completed DMC

• 1 other identifier: ISI-dVCR-003
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Colon Tumor; Malignant Colorectal Tumor; Benign Colorectal Neoplasm

Outcome Measures

Primary Outcomes (1)

• Number of SureForm™ Stapler fires and reload colors

  The primary endpoint of the study is to assess the number of fires and reload colors of SureForm™ Staplers utilized for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.

  During the procedure

Secondary Outcomes (1)

• Incidence of peri-operative and short term outcomes

  30 days post-operative

Study Arms (1)

Robotic-assisted colorectal resection

Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum.

Procedure: Colorectal resection

Interventions

Colorectal resection PROCEDURE

Robotic-assisted resection of the colon or rectum in subjects with benign or malignant colon or rectal disease, where SureForm™ Staplers are utilized for transection and/or creation of anastomosis.

Robotic-assisted colorectal resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject undergoing robotic-assisted colorectal procedure for suspected or confirmed benign or malignant colon or rectal disease.

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
• 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.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Oklahoma Surgical Hospital

Tulsa, Oklahoma, 74137, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 30, 2020
• Study Start: January 30, 2020
• Primary Completion: July 21, 2021
• Study Completion: December 31, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

US (1)