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Robot-Assisted surgery for colon tumors under study

NCT ID NCT04403022

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

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

60 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Adventist Health System/Sunbelt

    Orlando, Florida, 32803, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Ewha Womans University College of Medicine

    Seoul, Gangseo-gu, Gonghang-daero, South Korea

  • Henry Ford

    Detroit, Michigan, 48202, United States

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • MountianView Hospital

    Las Vegas, Nevada, 89128, United States

  • MultiCare - Tacoma

    Tacoma, Washington, 98405, United States

  • Ulsan University Hospital

    Ulsan, Dong-gu, 25 Daehakbyeongwon-ro, South Korea

More trials for these conditions

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