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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
Must not have
Subjects undergoing both LAR/TME and right colectomy during the same operation
Subjects with planned major concomitant procedures (eg. hepatectomies, other intestinal resections) or emergent case
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative through the 42-day postoperative period
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I can follow the study's schedule for check-ups and long-term follow-up for 5 years.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am having surgery for both lower rectum cancer and right colon cancer at the same time.
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I am scheduled for or might need a major surgery soon.
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My colonoscopy showed I have cancer in different parts of my colon at the same time.
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I do not have any uncontrolled illnesses that could affect my participation.
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My anal canal cancer needs surgery involving abdomen and perineum removal.
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I have a history of inflammatory bowel disease.
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My scans show very close cancer margins near my rectum.
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I cannot undergo surgery or general anesthesia due to health risks.
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My cancer has spread to other parts of my body.
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I had surgery before to fix a hernia with mesh.
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I have a condition that affects my blood's ability to clot.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative period
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events Rates
Performance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Colorectal procedure will be performed by da Vinci SP® Surgical System

Find a Location

Who is running the clinical trial?

Intuitive SurgicalLead Sponsor
77 Previous Clinical Trials
50,501 Total Patients Enrolled
Madhu L GorrepatiStudy DirectorClinical Affairs Director
Kathryn WineStudy DirectorMedical Affairs Director
1 Previous Clinical Trials
204 Total Patients Enrolled

Media Library

da Vinci SP Surgical System (Robotic Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT04403022 — N/A
Colorectal Cancer Research Study Groups: Single arm
Colorectal Cancer Clinical Trial 2023: da Vinci SP Surgical System Highlights & Side Effects. Trial Name: NCT04403022 — N/A
da Vinci SP Surgical System (Robotic Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04403022 — N/A
~14 spots leftby Nov 2025
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