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Robotic Surgery
Single Port Robotic Surgery for Colorectal Cancer
N/A
Recruiting
Led By Ankit Sarin, MD
Research Sponsored by Ankit Sarin, MD, MHA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial will test whether a robotically-assisted surgery platform, currently used for colorectal surgery indications, is safe and effective for use in head and neck surgery.
Who is the study for?
This trial is for adults over 18 with colorectal conditions like rectal prolapse or cancer, requiring surgery. Candidates must be in good health, not pregnant or lactating if female, and able to consent. Excluded are those with severe diseases, advanced cancer, prior chemo or radiation therapy, emergency operation needs, or inability to follow up.Check my eligibility
What is being tested?
The study tests a new Single Port (SP) robotic technology for colorectal surgeries against the standard multiport system. It aims to determine if the SP method is safe and effective for these types of surgeries which have been previously approved only for head and neck and urology procedures.See study design
What are the potential side effects?
While specific side effects aren't listed here as it's a surgical procedure being tested rather than a drug, potential risks may include typical surgical complications such as infection at the incision site, bleeding, pain post-surgery and possible issues related to robotic-assisted operations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Port Robotic Surgery ArmExperimental Treatment1 Intervention
Study subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system
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Who is running the clinical trial?
Yale UniversityOTHER
1,852 Previous Clinical Trials
2,738,416 Total Patients Enrolled
Ankit Sarin, MD, MHALead Sponsor
Ankit Sarin, MDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am in good health overall, as confirmed by my recent medical exams.My condition qualifies for a robotic procedure to remove a tumor in my rectum.I am over 18, not pregnant, not breastfeeding, and if I can have children, I use reliable birth control.I am under 18 years old.I am currently pregnant or breastfeeding.I am 18 years old or older.My cancer is in the advanced stage.I have had chemotherapy or radiation before surgery.I need an emergency surgery.I am in good health overall, as confirmed by my recent medical exams.I am eligible for a specific surgery for a condition in my lower rectum.I am not willing to attend follow-up assessments.I have a stable place to live and a phone.I have been postmenopausal for 2+ years, had a hysterectomy, or can't get pregnant.I understand and can agree to the study's requirements.I am not pregnant, breastfeeding, and if of childbearing age, have been infertile for 3 months.I have been diagnosed with colorectal cancer and am scheduled for robotic surgery.I do not have severe kidney, liver, nerve, heart, or lung diseases that would stop me from joining.I have been diagnosed with colorectal cancer and am scheduled for a robotic surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Single Port Robotic Surgery 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 new recruits still being welcomed for this investigation?
"Affirmative. Clinicaltrials.gov data corroborates that this experiment, initially posted on April 28th 2022, is still actively recruiting participants. The medical trial requires 25 individuals at a single site."
Answered by AI
How many participants are being observed in this research endeavor?
"Affirmative, the information posted on clinicaltrials.gov indicates that this research is actively recruiting participants. This experiment was initially published on April 28th 2022 and has since been updated May 20th of the same year. The goal is to recruit 25 individuals from a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Arizona
How old are they?
65+
18 - 65
What site did they apply to?
UCSF Medical Center at Mission Bay
What portion of applicants met pre-screening criteria?
Did not meet criteria
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