NCT06133387 · EndoQuest Robotics, Inc.
PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
(PARADIGM)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Scottsdale, Arizona
- Orlando, Florida
- Boston, Massachusetts
- Cleveland, Ohio
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations