Colo-rectal CancerNCT05321134
Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
A study testing Single port robotic colorectal surgical procedure in people with Colo-rectal Cancer and Rectal Prolapse, run by University of California, Davis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Rectal Prolapse, Colostomy Stoma
- What is being tested?
- Single port robotic colorectal surgical procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Ankit Sarin, MD
About this study
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.
Read the detailed description
This is a single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study where researchers will study colorectal surgical procedures done using the novel Single Port (SP) Robotic Platform and compare perioperative outcomes to colorectal surgical cases done using the traditional Multi-port (Xi) Robotic Platform.
AIM 1 To assess the feasibility and safety/quality of a SP platform for transabdominal and transanal colorectal operations which are currently done using multiport robotic platforms.
AIM 2 To evaluate safety and quality outcomes post SP surgery in comparison with contemporaneous standard multiport Xi platform procedures.
- Being tested
- Single port robotic colorectal surgical procedure
- Keywords
- robotic surgery, colorectal surgery, single port, Intuitive SP platform
- Medical subject headings
- Colonic Neoplasms, Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single port robotic colorectal surgical procedureDevice
After screening and counseling, study subjects who wish to participate will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the alternate Intuitive Da Vinci Single Port SP system rather than the currently used multiport system, (Intuitive Da Vinci Multiport Xi System).
Using standardized case report forms, the investigators will track clinical parameters and describe the safety \& quality event rate for SP platform transabdominal and transanal colorectal operations.
| Study group | Role | What they receive |
|---|---|---|
| Single Port Robotic Surgery Arm | Experimental | Study subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system Receives: Device: Single port robotic colorectal surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations
A safety \& quality event will be defined as occurring if any of the following occur:
- Conversion to open or laparoscopic procedure
- EBL > 200 ml, or
- Operative time > 90th percentile of all procedures with matching CPT code, or
- Positive pathological margins (if applicable), or
- Fragmented specimen (if applicable) or
- Unplanned ICU stay or
- Post-procedure LOS > 90th percentile of all procedures with matching CPT code, or
- Reoperation within 30 days or
- Post Procedure Pain > 90th percentile (visual analog score)
- Postoperative complication as defined by NSQIP (including SSI, DVT, PE, readmission, anastomotic Leak (if applicable)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start28 Apr 2022
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Yale University, Henry Ford Hospital, University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Ankit Sarin, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321134
- Sponsor's protocol ID
- 2022178
- Status last verified
- May 2026
- First submitted
- 31 Mar 2022
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sarin A, Barnes KE, Shui AM, Nakamura Y, Hoffman DB, Romero-Hernandez F, Chern H. Initial Experience With Single-Port Robotic Right Colectomies: Results of an Investigator-Initiated Investigational Device Exemption Study Using a Novel Single-Port Robotic Platform. Dis Colon Rectum. 2024 Oct 1;67(10):e1600-e1606. doi: 10.1097/DCR.0000000000003352. Epub 2024 Sep 5.
PubMed 39250792
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT05321134
- Acronym / sponsor ID
- 2022178
- Keywords
- robotic surgery, colorectal surgery, single port, Intuitive SP platform
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Yale University, Henry Ford Hospital, University of Massachusetts, Worcester
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study where researchers will study colorectal surgical procedures done using the novel Single Port (SP) Robotic Platform and compare perioperative outcomes to colorectal surgical cases done using the traditional Multi-port (Xi) Robotic Platform.
AIM 1 To assess the feasibility and safety/quality of a SP platform for transabdominal and transanal colorectal operations which are currently done using multiport robotic platforms.
AIM 2 To evaluate safety and quality outcomes post SP surgery in comparison with contemporaneous standard multiport Xi platform procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study
| Arm | Type | Receives |
|---|---|---|
| Single Port Robotic Surgery Arm | Experimental | Device: Single port robotic colorectal surgical procedureStudy subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single port robotic colorectal surgical procedureAfter screening and counseling, study subjects who wish to participate will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the alternate Intuitive Da Vinci Single Port SP system rather than the currently used multiport system, (Intuitive Da Vinci Multiport Xi System). Using standardized case report forms, the investigators will track clinical parameters and describe the safety \& quality event rate for SP platform transabdominal and transanal colorectal operations. | Device | Single Port Robotic Surgery Arm |
Primary outcome
Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations
Time frame: 30 days
A safety \& quality event will be defined as occurring if any of the following occur: * Conversion to open or laparoscopic procedure * EBL > 200 ml, or * Operative time > 90th percentile of all procedures with matching CPT code, or * Positive pathological margins (if applicable), or * Fragmented specimen (if applicable) or * Unplanned ICU stay or * Post-procedure LOS > 90th percentile of all procedures with matching CPT code, or * Reoperation within 30 days or * Post Procedure Pain > 90th percentile (visual analog score) * Postoperative complication as defined by NSQIP (including SSI, DVT, PE, readmission, anastomotic Leak (if applicable)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 39250792Sarin A, Barnes KE, Shui AM, Nakamura Y, Hoffman DB, Romero-Hernandez F, Chern H. Initial Experience With Single-Port Robotic Right Colectomies: Results of an Investigator-Initiated Investigational Device Exemption Study Using a Novel Single-Port Robotic Platform. Dis Colon Rectum. 2024 Oct 1;67(10):e1600-e1606. doi: 10.1097/DCR.0000000000003352. Epub 2024 Sep 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ankit Sarin, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single port robotic colorectal surgical procedure in people with Colo-rectal Cancer and Rectal Prolapse, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ankit Sarin, MD (9167034472, axsarin@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05321134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.