Early Rectal NeoplasmsNCT07486180
The Application of a Novel Endoluminal Robotic System for Colorectal Endoscopic Submucosal Dissection
A study testing Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System in people with Early Rectal Neoplasms, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Rectal Neoplasms
- What is being tested?
- Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Simon SM Ng, MD, +852-35051495, simonng@surgery.cuhk.edu.hk
Kaori Futaba, MD, +852-35051495, kfutaba@surgery.cuhk.edu.hk
About this study
Official title: Performance, Feasibility, and Safety Study For A Novel Endoluminal Robotic System for Colorectal Endoscopic Submucosal Dissection (ESD): First-in-Human Trial
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.
- Conditions
- Early Rectal Neoplasms
- Being tested
- Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System
- Keywords
- Early rectal neoplasms, Rectal adenomas, T1 rectal cancer, ESD, Endoluminal robotic system
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical SystemProcedure or surgery
Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System | Experimental | Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics Receives: Procedure: Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
En bloc resection rate
The definition of en bloc resection is resection with a single piece.
Measured: 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.
Measured: Up to 1 month
Secondary outcomes (7)
R0 resection rate
R0 resection is defined as complete resection of the neoplasm with clear lateral and deep margins at histology
Measured: 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.
Measured: 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).
Measured: 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)
Measured: Perioperative
Time to resume normal diet
Measured: Up to 1 month
Time to walk independently
Measured: Up to 1 month
Length of hospital stay
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon S. M. Ng, Chinese University of Hong Kong
- Investigators
- Simon SM Ng, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486180
- Sponsor's protocol ID
- CREC 2026.119
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance, Feasibility, and Safety Study For A Novel Endoluminal Robotic System for Colorectal Endoscopic Submucosal Dissection (ESD): First-in-Human Trial
- ClinicalTrials.gov ID
- NCT07486180
- Acronym / sponsor ID
- CREC 2026.119
- Conditions
- Early Rectal Neoplasms
- Keywords
- Early rectal neoplasms, Rectal adenomas, T1 rectal cancer, ESD, Endoluminal robotic system
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System | Experimental | Procedure: Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical SystemColorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical SystemColorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics | Procedure or surgery | Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System |
Primary outcome
En bloc resection rate
Time frame: Perioperative
The definition of en bloc resection is resection with a single piece.
Perioperative complications
Time frame: Up to 1 month
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.
7 secondary outcomes
R0 resection rate
Time frame: Perioperative
Endoscopic Submucosal Dissection (ESD) procedure time
Time frame: Perioperative
Endoscopic Submucosal Dissection (ESD) dissection speed
Time frame: Perioperative
Conversion rate
Time frame: Perioperative
Time to resume normal diet
Time frame: Up to 1 month
Time to walk independently
Time frame: Up to 1 month
Length of hospital stay
Time frame: Up to 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon SM Ng, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System in people with Early Rectal Neoplasms, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon SM Ng, MD (+852-35051495, simonng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
En bloc resection rate (time frame: Perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.