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Robot arm takes on colon polyps: new study tests less invasive removal

NCT ID NCT06133387

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 2 times

Summary

This study is testing a robotic device that doctors use through the anus to remove benign growths (polyps, adenomas) from the rectum and sigmoid colon. The goal is to see if the device can remove the entire growth in one piece safely, without causing bleeding or a hole in the bowel. About 56 adults with such growths will be treated and followed for 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endoluminal Surgical (ELS) System (robotic device)
What this could lead to
If successful, this robotic device could offer a less invasive way to remove colorectal polyps and adenomas, reducing the need for traditional surgery.
What could go wrong
This is an early-stage study with only 56 participants, so results may not apply widely. Risks include bleeding or perforation during the procedure.

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

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Aug 2026

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

22 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.

Preoperative Inclusion Criteria: 1. Subject is ≥22 years at the time of consent. 2. Subject has a BMI ≤ 50 kg/m2. 3. Subject has an ASA score of ≤ 3. 4. Subject has benign lesion(s) of the rectum or sigmoid colon, such as adenoma (with low- or high-grade dysplasia), neuroendocrine tumor, or other type of polyp as assessed by the most recent colonoscopy/flexible sigmoidoscopy. 5. Subject has lesion ≤ 7 cm in size (dimension of greatest extent) and ≤ 75% of the colorectal circumference as assessed by the most recent colonoscopy/flexible sigmoidoscopy. 6. Subject is eligible for standard endoscopic submucosal dissection. 7. Subject agrees to participate in the study by giving signed informed consent. Preoperative Exclusion Criteria: 1. Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery. 2. Subject has active left-sided inflammatory bowel disease. 3. Subject has an untreated active infection at the time of the procedure. 4. Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled). 5. Subject has a severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (e.g., cancer). 6. Subject is breastfeeding or pregnant or intends to become pregnant during the study. 7. Subject is currently enrolled in or discontinued within the last 30 days from a clinical trial of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 8. Subject with EF ≤ 45, high cardiac or high pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist, as applicable). 9. Subject on preoperative blood thinners, such as coumadin or heparin, that cannot be weaned prior to surgery. 10. Subject is moderately or severely immunocompromised. 11. In the opinion of the Investigator, the subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. Intraoperative Exclusion Criteria (assessed with third-party endoscope): 1. Inadequate bowel prep. 2. Complex anatomical findings not feasible for an endoluminal approach. 3. Anatomical narrowing distal to the lesion site. 4. Lesion not located in the rectum or sigmoid colon. 5. Lesion size \>7 cm (dimension of greatest extent) or occupies \>75% of the colorectal circumference. 6. Lesion demonstrates characteristics indicative of invasive carcinoma, such as failure to lift upon submucosal injection, or any other features that raise the Investigator's suspicion of cancer. Intraoperative Exclusion Criteria (assessed with study device): 7. In the opinion of the Investigator, the subject and/or subject anatomy is not suitable for study device use for any reason. 8. Lesion location not accessible by the study device.

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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

  • AdventHealth

    Orlando, Florida, 32803, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • HCA Healthcare

    Houston, Texas, 77004, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

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