RecruitingNot applicable

Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a single-port robotic system can be used safely and effectively for surgery on the colon or rectum. It is for adults with a condition in these parts of the bowel who have plans for robotic surgery.

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. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You have a documented condition of the colon or rectum that needs surgery, with plans for a robotic operation.
  • For surgery through the anus, you must meet standard guidelines. Eligible growths include early rectal cancer with no lymph node spread, precancerous growths, or certain hormone-making tumors that have not spread. They must be within 15 cm of the anal opening.
  • Your health history and physical exam show that you are in good general health.
  • If you can become pregnant, you must have a negative urine pregnancy test and not be breastfeeding. You must use an allowed birth control method for at least 1 month before joining and during the study, or avoid sex. If you start having sex, you must start an allowed method.
  • If you cannot become pregnant, this must have been true for at least 3 months. This can mean menopause for at least 2 years, surgery to remove the womb or tie both tubes, or other proof that pregnancy is not possible.
  • You can and will give written consent, follow study rules, and complete study checks.
  • You have a stable place to live and a telephone.

Who can't join

  • You are under 18, pregnant, or breastfeeding.
  • You have a severe illness that constantly threatens your life, or you are not expected to survive without surgery.
  • You have serious kidney, liver, nerve, heart, or long-term lung disease that the study doctor believes makes participation unsafe.
  • You have advanced or stage IV cancer.
  • You have received chemotherapy or radiation before surgery.
  • You need emergency surgery.
  • You cannot fully understand the study or give consent.
  • You are unwilling to attend follow-up checks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 prior to use of study product. To be considered to be not of childbearing potential, the subject must be postmenopausal for at least 2 years; have had a hysterectomy or bilateral tubal ligation, or be proven to be otherwise incapable of pregnancy. If of childbearing potential, the subject must have been practicing one of the following methods of contraception consistently for at least 1 month prior to study entry and agree to continue practicing it during the study: hormonal contraceptives, intrauterine device, spermicide and barrier, spouse/partner sterility; or is practicing abstinence and agrees to continue abstinence or to start an acceptable method of contraception from the above list if sexual activity commences. * 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 anal verge. * 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. Exclusion Criteria: * 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.

Study sites (1)

CA