Robot-Assisted surgery for colon tumors under study
NCT ID NCT04403022
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well a new robotic surgical system works for removing colon or rectal tumors. About 60 adults who need surgery for benign or malignant colorectal conditions will take part. The goal is to see if the system is safe and can complete the surgery without switching to another method.
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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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60 people
The number who actually took part.
- Started
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Jun 2021
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * BMI ≤ 35 * Candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures * ASA ≤ 3 * Willing and able to provide a written informed consent document * Willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years Exclusion Criteria: * Clinical or radiological evidence of metastatic disease * Life expectancy less than 6 months * Cancer of the anal canal requiring an abdominoperineal resection * Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR ONLY) * Subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case * Subjects undergoing both LAR/TME and right colectomy during the same operation * Preoperative colonoscopy demonstrating synchronous colorectal cancer * History of inflammatory bowel disease * Subject has a known bleeding or clotting disorder * Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Subject is contraindicated for general anesthesia or surgery * Subject had prior incisional hernia with mesh repair * Subject belongs to vulnerable population * Subject is pregnant or suspected to be pregnant Intraoperative Exclusion Criteria: • Subject presents with adhesions or scarring in the pelvis which in the opinion of the investigator limits the ability to perform the minimally invasive procedure
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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.
Contacts and locations
Locations
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Adventist Health System/Sunbelt
Orlando, Florida, 32803, United States
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Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
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Ewha Womans University College of Medicine
Seoul, Gangseo-gu, Gonghang-daero, South Korea
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Henry Ford
Detroit, Michigan, 48202, United States
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Houston Methodist Research Institute
Houston, Texas, 77030, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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MountianView Hospital
Las Vegas, Nevada, 89128, United States
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MultiCare - Tacoma
Tacoma, Washington, 98405, United States
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Ulsan University Hospital
Ulsan, Dong-gu, 25 Daehakbyeongwon-ro, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- The gatekeepers of tumors: scientists probe how blood vessels let immune cells in
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers