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Robotic Surgery
Robotic Assisted Surgery for Colorectal Cancer
N/A
Waitlist Available
Led By David Larson, MD, MBA
Research Sponsored by Intuitive Surgical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative through the 42-day postoperative period
Awards & highlights
Study Summary
This trial is testing the safety and performance of the da Vinci SP surgical system in complex colorectal procedures.
Who is the study for?
Adults with colorectal cancer who need complex surgery and have a BMI ≤ 35, ASA score ≤ 3 (indicating they're fit for surgery), and no widespread cancer. They must be able to follow the study plan, including visits up to 5 years after surgery.Check my eligibility
What is being tested?
The trial is testing the safety and performance of the da Vinci SP Surgical System in single-port robotic-assisted surgeries like low anterior resections or right colectomies for colorectal cancer.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks such as pain, infection at the incision site, bleeding, blood clots, and reactions to anesthesia. Specific side effects related to robotic-assisted surgery will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can follow the study's schedule for check-ups and long-term follow-up for 5 years.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events Rates
Performance
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Colorectal procedure will be performed by da Vinci SP® Surgical System
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Who is running the clinical trial?
Intuitive SurgicalLead Sponsor
73 Previous Clinical Trials
49,199 Total Patients Enrolled
Kathryn WineStudy DirectorMedical Affairs Director
1 Previous Clinical Trials
204 Total Patients Enrolled
David Larson, MD, MBAPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery for both lower rectum cancer and right colon cancer at the same time.I am scheduled for or might need a major surgery soon.My colonoscopy showed I have cancer in different parts of my colon at the same time.I can follow the study's schedule for check-ups and long-term follow-up for 5 years.I do not have any uncontrolled illnesses that could affect my participation.My anal canal cancer needs surgery involving abdomen and perineum removal.I have a history of inflammatory bowel disease.My scans show very close cancer margins near my rectum.I cannot undergo surgery or general anesthesia due to health risks.My cancer has spread to other parts of my body.I am 18 years old or older.I had surgery before to fix a hernia with mesh.I have a condition that affects my blood's ability to clot.I am eligible for a specific type of minimally invasive surgery for my colon or rectal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies still available in this research effort?
"Affirmative. Clinicaltrials.gov data reveals that this clinical trial, which was initially posted on June 3rd 2021, is actively recruiting patients. This investigation requires the recruitment of 60 participants from three distinct sites."
Answered by AI
What is the maximum capacity for participants in this experiment?
"In order to complete this clinical trial, 60 volunteers who meet the pre-determined qualifications must partake in it. Participants may have access to these medical services at Adventist Health System/Sunbelt in Orlando or Mayo Clinic in Rochester."
Answered by AI
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