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

January 3, 2024 updated by: Intuitive Surgical
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-center observational study to evaluate the performance of SureForm™ Staplers during robotic-assisted resections of either ascending or transverse or descending or sigmoid colon or rectum. 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 will be asked to provide informed consent for their participation in the study.

The study will be conducted at one institution with two surgeons performing the colorectal procedures. The surgeons will be using either the da Vinci Xi or X Surgical System which ever they use as per their standard of care for the colorectal procedure. Stapling will be performed with SureForm™ Staplers and any of the reloads as per the surgeon's standard of care for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Oklahoma Surgical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of SureForm™ Stapler fires and reload colors
Time Frame: During the procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of peri-operative and short term outcomes
Time Frame: 30 days post-operative
The secondary endpoint of the study is to assess the incidence of peri-operative and short term outcomes following transection and/or creation of anastomosis using SureForm™ Staplers during robotic-assisted colorectal procedures.
30 days post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2020

Primary Completion (Actual)

July 21, 2021

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISI-dVCR-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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