NCT07486180Not yet recruiting
The Application of a Novel Endoluminal Robotic System for Colorectal Endoscopic Submucosal Dissection
Performance, Feasibility, and Safety Study For A Novel Endoluminal Robotic System for Colorectal Endoscopic Submucosal Dissection (ESD): First-in-Human Trial
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
Endoluminal surgery through natural orifices is an effective, "incisionless" treatment for benign lesions and early-stage cancers in the urinary tract and gastrointestinal (GI) tract. However, current practice suffers from the use of basic surgical instruments that lack dexterity and the ability to perform effective tissue retraction and provide triangulation. This is illustrated in endoscopic submucosal dissection (ESD) of GI tumors, which is a highly effective technique that has limited widespread adoption due to the exceptionally steep learning curve created by unintuitive and cumbersome instruments. It is suggested that a robotic system may improve en bloc resection capabilities in the GI tract by providing surgeons with dexterous and precise bimanual instrument control. This study aims to evaluate the clinical feasibility and safety of colorectal ESD using a novel endoluminal robotic system - the Intilume System by Agilis Robotics. It is a prospective, single center study consistent with a Stage 1 (Innovation) study described in the Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) framework. The primary study endpoints are en bloc resection rate and perioperative complications. The secondary study endpoints include R0 resection rate, dissection related metrics, conversion rate, and post-procedure recovery. This study will provide information on the feasibility and safety of the Intilume System developed by Agilis Robotics in performing colorectal ESD. This study may provide pertinent evidence for the continued development of this robotic technology.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 17 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Colorectal cancer
- NCT number
- NCT07486180
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 Apr 2026 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are indicated for surgical resection
- Patients with recurrence from previous EMR or ESD
Other illness
- Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion)
Other
- Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology, Kudo's pit pattern Type V, or Sano's capillary pattern Type IIIB)
- Evidence of deep invasion on endorectal ultrasonography
- Patients with non-correctable coagulopathy
- Patients with contraindications to general anesthesia
- Vulnerable population (e.g., mentally disabled, pregnancy.)
Who the study is looking for
- Patients diagnosed with nonpedunculated early rectal neoplasms \>/= 2 cm in size in the rectum (\>/= 3 cm and \</= 18 cm from the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or endoscopic mucosal resection (EMR) as judged by two experienced endoscopists
- American Society of Anesthesiologists (ASA) grading I-III
- Informed consent available
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital, The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.