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New treatment option for Colo-rectal Cancer
Official title Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
ClinicalTrials.gov ID: NCT05321134
What this study is testing
- What it's testing
- Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject is male or female, greater than or equal to 18 years of age. If female, the subject has a negative urine pregnancy test and is not...
- There is documentation of a colorectal diagnosis requiring operative interventions with clinical plans for a robotic operation.
- For robotic transanal procedures, patients who would meet standard guidelines for a transanal procedures (T1N0 rectal adenocarcinoma, Precancerous...
- The subject is in good general health as evidenced by medical history and physical examination
- The subject is able and willing to provide written informed consent.
You likely can't join if
- The subject is child less than 18 years of age
- The subject is a female who is pregnant or lactating
- The subject falls under the American Society of Anesthesia Class IV (Patients with severe systemic disease that is a constant threat to life).
- The subject falls under American Society of Anesthesia Class V (Moribund patients who is not expected to survive without the operation)
- The subject has a history of clinically significant renal, hepatic, neurological, cardiac or chronic pulmonary disease that in the judgment of the...
- The subject has advanced/ Stage IV cancer
See the full eligibility criteria
- The subject is male or female, greater than or equal to 18 years of age. If female, the subject has a negative urine pregnancy test and is not lactating, or has not been of childbearing potential for at least 3 months...
- There is documentation of a colorectal diagnosis requiring operative interventions with clinical plans for a robotic operation.
- For robotic transanal procedures, patients who would meet standard guidelines for a transanal procedures (T1N0 rectal adenocarcinoma, Precancerous adenomas, and localized neuroendocrine tumors) distal to 15 cm from the...
- The subject is in good general health as evidenced by medical history and physical examination
- The subject is able and willing to provide written informed consent.
- The subject agrees to comply with the requirements of the protocol and complete study measures.
- The subject has stable residence and telephone.
- The subject is child less than 18 years of age
- The subject is a female who is pregnant or lactating
- The subject falls under the American Society of Anesthesia Class IV (Patients with severe systemic disease that is a constant threat to life).
- The subject falls under American Society of Anesthesia Class V (Moribund patients who is not expected to survive without the operation)
- The subject has a history of clinically significant renal, hepatic, neurological, cardiac or chronic pulmonary disease that in the judgment of the investigator precludes participation.
- The subject has advanced/ Stage IV cancer
- The subject has received neo-adjuvant chemotherapy or radiation therapy
- The subject requires an emergency operation.
- The subject is unable to fully comprehend or consent to the study
- The subject is unwilling to be available for follow-up assessments.
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.