PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System

Launched by ENDOQUEST ROBOTICS, INC. · Nov 10, 2023

Keywords

ClinConnect Summary

The PARADIGM - En Bloc Trial is a study looking at a new method called the Endoluminal Surgical (ELS) System to treat certain non-cancerous growths (like polyps or adenomas) in the rectum and sigmoid colon. This trial aims to find out how safe and effective this system is for patients undergoing a specific procedure called endoscopic submucosal dissection (ESD), which helps remove these growths. Participants will be monitored closely during the procedure and also checked at discharge, and again at one week and one month after the procedure.

To join the trial, participants should be between 22 to 80 years old and have benign lesions that meet certain size and health criteria. They should not have any serious health issues that could complicate the procedure, nor should they be currently pregnant or breastfeeding. If eligible, participants can expect to undergo the procedure with careful oversight from medical professionals, and they'll receive follow-up care to ensure their recovery is going well. This trial is currently recruiting participants of all genders.

Gender

ALL

Eligibility criteria

• Preoperative Inclusion Criteria:
• • 1. Subject is between the ages of 22 to 80 years at the time of consent.
• • 2. Subject has a BMI ≤ 50 kg/m2.
• • 3. Subject has an ASA score of ≤ 3.
• • 4. 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.
• • 5. 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.
• • 6. Subject is eligible for standard endoscopic submucosal dissection.
• • 7. Subject agrees to participate in the study by giving signed informed consent.
• Preoperative Exclusion Criteria:
• • 1. Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.
• • 2. Subject has a history of inflammatory bowel disease.
• • 3. Subject has an untreated active infection at the time of the procedure.
• • 4. Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled).
• • 5. Subject has a severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (e.g., cancer).
• • 6. Subject is breastfeeding or pregnant or intends to become pregnant during the study.
• • 7. 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.
• • 8. Subject with EF ≤ 45, high cardiac or high pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist, as applicable).
• • 9. Subject on preoperative blood thinners, such as coumadin or heparin, that cannot be weaned prior to surgery.
• • 10. Subject is moderately or severely immunocompromised.
• • 11. 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):
• • 1. Inadequate bowel prep.
• • 2. Complex anatomical findings not feasible for an endoluminal approach.
• • 3. Anatomical narrowing distal to the lesion site.
• • 4. Lesion not located in the rectum or sigmoid colon.
• • 5. Lesion size \>7 cm (dimension of greatest extent) or occupies \>75% of the colorectal circumference.
• • 6. 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):
• • 7. In the opinion of the Investigator, the subject and/or subject anatomy is not suitable for study device use for any reason.
• • 8. Lesion location not accessible by the study device.