Colorectal LesionPARADIGMNCT06133387
PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
A study testing Endoscopic submucosal dissection using the ELS System in people with Colorectal Lesion and Colorectal Adenoma, run by EndoQuest Robotics, Inc. at 6 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Colorectal Lesion, Colorectal Adenoma, Colorectal Polyp
- What is being tested?
- Endoscopic submucosal dissection using the ELS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 May 2025to Aug 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Preoperative Inclusion Criteria:
- Subject is ≥22 years at the time of consent.
- Subject has a BMI ≤ 50 kg/m2.
- Subject has an ASA score of ≤ 3.
- 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.
- 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.
- Subject is eligible for standard endoscopic submucosal dissection.
- Subject agrees to participate in the study by giving signed informed consent.
Preoperative Exclusion Criteria:
- Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.
- Subject has active left-sided inflammatory bowel disease.
- Subject has an untreated active infection at the time of the procedure.
- Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled).
- Subject has a severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (e.g., cancer).
- Subject is breastfeeding or pregnant or intends to become pregnant during the study.
- 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.
- Subject with EF ≤ 45, high cardiac or high pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist, as applicable).
- Subject on preoperative blood thinners, such as coumadin or heparin, that cannot be weaned prior to surgery.
- Subject is moderately or severely immunocompromised.
- 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):
- Inadequate bowel prep.
- Complex anatomical findings not feasible for an endoluminal approach.
- Anatomical narrowing distal to the lesion site.
- Lesion not located in the rectum or sigmoid colon.
- Lesion size >7 cm (dimension of greatest extent) or occupies >75% of the colorectal circumference.
- 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):
- In the opinion of the Investigator, the subject and/or subject anatomy is not suitable for study device use for any reason.
- Lesion location not accessible by the study device.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44195
HCA Healthcare
Houston, Texas, 77004
Baylor College of Medicine
Houston, Texas, 77030
AdventHealth
Orlando, Florida, 32803
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.
The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.
Read the detailed description
This study will be a prospective, single treatment, multi-center, open-label clinical study. The objective of this study is to evaluate the safety and effectiveness of the ELS System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon (up to 7 cm in size and up to 75% of the colorectal circumference).
The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge, Day 7 (-2 +7 days) and Day 30 (-7 +14 days).
Subjects with lesions resected using the study device will be allocated into two different study arms:
Arm 1:
- Subjects with benign final pathology and R0 resection is achieved; or,
- Subjects with benign (but not pre-cancerous) final pathology without R0 resection.
Arm 2:
- Subjects with final pathology that is upstaged to cancer; or,
- Subjects with benign (and pre-cancerous) final pathology without R0 resection.
Subjects in Arm 1 will complete the study after Day 30. Arm 1 subjects in which R0 resection was not achieved should receive routine care, including any additional treatment as needed at the discretion of the physician, even if occurring after study exit at Day 30. Any non-study-related care of Arm 1 subjects occurring after study exit may be performed by the Investigator or transferred to another physician at the discretion of the Investigator and will not be collected for this trial.
Subjects in Arm 2 will undergo 5-year follow-up to assess long-term oncological outcomes including local recurrence, disease-free survival and overall survival.
To ensure a total of 50 subjects are included in the final analysis, the study may enroll up to 56 subjects at up to 6 clinical sites in the U.S. No individual site will be permitted to enroll more than 60% of the subjects in the final data set to ensure that a single site does not dominate the results and analysis. Enrollment will end when 50 subjects have completed 30-day follow-up or the maximum enrollment number has been reached, whichever occurs first.
In addition to the total number of enrolled subjects, each Investigator will enroll up to 2 lead-in cases. Lead-in cases will be analyzed separately in the final clinical study report.
- Conditions
- Colorectal Lesion, Colorectal Adenoma, Colorectal Polyp, Rectal Lesion, Rectal Adenoma, Rectal Polyp
- Being tested
- Endoscopic submucosal dissection using the ELS System
- Keywords
- Rectal Lesion, Sigmoid Lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic submucosal dissection using the ELS SystemDevice
All subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | * Subjects with benign final pathology and R0 resection is achieved; or,
* Subjects with benign (but not pre-cancerous) final pathology without R0 resection.
Subjects in Arm 1 will complete the study after Day 30. Receives: Device: Endoscopic submucosal dissection using the ELS System |
| Arm 2 | Experimental | * Subjects with final pathology that is upstaged to cancer; or,
* Subjects with benign (and pre-cancerous) final pathology without R0 resection.
Subjects in Arm 2 will undergo 5-year follow-up to assess long-term oncological outcomes including local recurrence, disease-free survival and overall survival. Receives: Device: Endoscopic submucosal dissection using the ELS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
En Bloc Resection Rate
The percentage of target lesions across all subjects that are excised in a single specimen.
Measured: On Day 0 (day of procedure)
ESD-Related Complication-Free Rate
The percentage of subjects free from study device-related bleeding and perforation complications intraoperatively and postoperatively through Day 30.
Measured: From enrollment to Day 30.
Secondary outcomes (2)
R0 Resection Rate
The percentage of target lesions across all subjects that are resected with lateral and deep margins free of residual disease under microscopic visualization.
Measured: On Day 0 (day of procedure)
Conversion-Free Rate
The percentage of intended resections that do not require conversion to achieve successful completion of the resection.
Measured: On Day 0 (day of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start13 May 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal LesionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EndoQuest Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133387
- Sponsor's protocol ID
- CIP-0001-Rev F
- Acronym
- PARADIGM
- Status last verified
- Jul 2026
- First submitted
- 10 Nov 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
- ClinicalTrials.gov ID
- NCT06133387
- Acronym / sponsor ID
- PARADIGM / CIP-0001-Rev F
- Conditions
- Colorectal Lesion, Colorectal Adenoma, Colorectal Polyp, Rectal Lesion, Rectal Adenoma, Rectal Polyp
- Keywords
- Rectal Lesion, Sigmoid Lesion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- EndoQuest Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 May 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Nov 2023 (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.
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.
The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.
Detailed description
This study will be a prospective, single treatment, multi-center, open-label clinical study. The objective of this study is to evaluate the safety and effectiveness of the ELS System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon (up to 7 cm in size and up to 75% of the colorectal circumference).
The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge, Day 7 (-2 +7 days) and Day 30 (-7 +14 days).
Subjects with lesions resected using the study device will be allocated into two different study arms:
Arm 1:
- Subjects with benign final pathology and R0 resection is achieved; or,
- Subjects with benign (but not pre-cancerous) final pathology without R0 resection.
Arm 2:
- Subjects with final pathology that is upstaged to cancer; or,
- Subjects with benign (and pre-cancerous) final pathology without R0 resection.
Subjects in Arm 1 will complete the study after Day 30. Arm 1 subjects in which R0 resection was not achieved should receive routine care, including any additional treatment as needed at the discretion of the physician, even if occurring after study exit at Day 30. Any non-study-related care of Arm 1 subjects occurring after study exit may be performed by the Investigator or transferred to another physician at the discretion of the Investigator and will not be collected for this trial.
Subjects in Arm 2 will undergo 5-year follow-up to assess long-term oncological outcomes including local recurrence, disease-free survival and overall survival.
To ensure a total of 50 subjects are included in the final analysis, the study may enroll up to 56 subjects at up to 6 clinical sites in the U.S. No individual site will be permitted to enroll more than 60% of the subjects in the final data set to ensure that a single site does not dominate the results and analysis. Enrollment will end when 50 subjects have completed 30-day follow-up or the maximum enrollment number has been reached, whichever occurs first.
In addition to the total number of enrolled subjects, each Investigator will enroll up to 2 lead-in cases. Lead-in cases will be analyzed separately in the final clinical study report.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Endoscopic submucosal dissection using the ELS System* Subjects with benign final pathology and R0 resection is achieved; or, * Subjects with benign (but not pre-cancerous) final pathology without R0 resection. Subjects in Arm 1 will complete the study after Day 30. |
| Arm 2 | Experimental | Device: Endoscopic submucosal dissection using the ELS System* Subjects with final pathology that is upstaged to cancer; or, * Subjects with benign (and pre-cancerous) final pathology without R0 resection. Subjects in Arm 2 will undergo 5-year follow-up to assess long-term oncological outcomes including local recurrence, disease-free survival and overall survival. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Endoscopic submucosal dissection using the ELS SystemAll subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon. | Device | Arm 1, Arm 2 |
Primary outcome
En Bloc Resection Rate
Time frame: On Day 0 (day of procedure)
The percentage of target lesions across all subjects that are excised in a single specimen.
ESD-Related Complication-Free Rate
Time frame: From enrollment to Day 30.
The percentage of subjects free from study device-related bleeding and perforation complications intraoperatively and postoperatively through Day 30.
2 secondary outcomes
R0 Resection Rate
Time frame: On Day 0 (day of procedure)
Conversion-Free Rate
Time frame: On Day 0 (day of procedure)
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 22 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic submucosal dissection using the ELS System in people with Colorectal Lesion and Colorectal Adenoma, run by EndoQuest Robotics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
En Bloc Resection Rate (time frame: On Day 0 (day of procedure)). 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 22 Jul 2026.