beta
Trial Radar AI
Clinical Trial NCT07486180 for Early Rectal Neoplasms is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

The Application of a Novel Endoluminal Robotic System for Colorectal Endoscopic Submucosal Dissection 10 Novel Treatment

Not yet recruiting
Clinical Trial NCT07486180 is an interventional study for Early Rectal Neoplasms and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 10 participants. Led by Chinese University of Hong Kong, this study is expected to complete by 1 April 2027. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
Brief Summary
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 (...Show More
Official Title

Performance, Feasibility, and Safety Study For A Novel Endoluminal Robotic System for Colorectal Endoscopic Submucosal Dissection (ESD): First-in-Human Trial

Conditions
Early Rectal Neoplasms
Other Study IDs
  • CREC 2026.119
NCT ID Number
NCT07486180
Start Date (Actual)
2026-04
Last Update Posted
2026-03-20
Completion Date (Estimated)
2027-04
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Early rectal neoplasms
Rectal adenomas
T1 rectal cancer
ESD
Endoluminal robotic system
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalColorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System
Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics
Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System
Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
En bloc resection rate
The definition of en bloc resection is resection with a single piece.
Perioperative
Perioperative complications
Perioperative complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification.
Up to 1 month
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
R0 resection rate
R0 resection is defined as complete resection of the neoplasm with clear lateral and deep margins at histology
Perioperative
Endoscopic Submucosal Dissection (ESD) procedure time
Endoscopic Submucosal Dissection (ESD) procedure time is defined as the total duration (in minutes) from the initial submucosal injection (or first marking) to the final removal of the lesion. It typically includes two phases: the circumferential mucosal incision (CIS) and the subsequent submucosal dissection (SDS) phase.
Perioperative
Endoscopic Submucosal Dissection (ESD) dissection speed
Endoscopic Submucosal Dissection (ESD) dissection speed is defined as the surface area of the resected specimen (in cm² or mm²) divided by the time taken (in minutes or hours).
Perioperative
Conversion rate
Conversion rate is defined as an emergent change in the treatment plan to conventional endoscopic submucosal dissection (ESD) or transanal minimally invasive surgery (TAMIS)
Perioperative
Time to resume normal diet
Up to 1 month
Time to walk independently
Up to 1 month
Length of hospital stay
Up to 1 month
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
  • Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion)
  • 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
  • Patients with non-correctable coagulopathy
  • Patients with contraindications to general anesthesia
  • Vulnerable population (e.g., mentally disabled, pregnancy.)
Chinese University of Hong Kong logoChinese University of Hong Kong474 active studies to explore
Study Responsible Party
Simon S. M. Ng, Principal Investigator, Wei Lun Professor of Surgery, Chinese University of Hong Kong
Study Central Contact
Contact: Simon SM Ng, MD, +852-35051495, [email protected]
Contact: Kaori Futaba, MD, +852-35051495, [email protected]
1 Study Locations in 1 Countries
Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China
Simon SM Ng, MD, Contact, +852-35051495, [email protected]
Kaori Futaba, MD, Contact, +852-35051495, [email protected]