Single-Port robot could make colorectal surgery less invasive
NCT ID NCT05321134
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new single-port robotic system for colorectal surgeries, such as for cancer or rectal prolapse. The goal is to see if it is safe and works as well as current multi-port robots. About 25 adults will take part, and researchers will track complications and recovery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UC Davis Medical Center
RECRUITINGSacramento, California, 95817, United States
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