ELS System for Colon Polyps

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: EndoQuest Robotics, Inc.

Must not be taking: Blood thinners

Disqualifiers: Inflammatory bowel disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

56 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but if you are on blood thinners like coumadin or heparin, you must be able to stop them before surgery.

What data supports the effectiveness of the ELS System treatment for colon polyps?

Research shows that endoscopic submucosal dissection (ESD) is effective in removing large colonic polyps in one piece, which can prevent the need for more invasive surgery. Studies have demonstrated high success rates in complete removal of these polyps, indicating the treatment's effectiveness. ^{1 2 3 4 5}

Is the ELS System for Colon Polyps safe for humans?

Endoscopic submucosal dissection (ESD), which includes the ELS System, is generally considered safe for removing large colon polyps, but it can have risks like bleeding and perforation (a hole in the colon). Safety measures and proper training are important to minimize these risks. ^{1 6 7 8 9}

How is the ELS System treatment for colon polyps different from other treatments?

The ELS System for colon polyps is unique because it uses an overtube system that creates a 'therapeutic zone' and allows for active retraction, which makes the procedure easier and reduces the risk of deep bowel wall injuries compared to traditional endoscopic submucosal dissection (ESD). This system also requires less lifting solution, making the process more efficient. ^{2 7 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 22-80 with a BMI ≤ 50 kg/m2 and an ASA score of ≤ 3, who have benign lesions in the rectum or sigmoid colon. Lesions must be ≤7 cm in size and cover no more than 75% of the colorectal circumference. Participants must consent to undergo endoscopic submucosal dissection.

Inclusion Criteria

I am between 22 and 80 years old.

Your body mass index (BMI) is less than or equal to 50.

Your overall health is rated as a 3 or lower on a scale called the ASA score.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo endoscopic submucosal dissection (ESD) with the ELS System for benign lesions in the rectum and sigmoid colon

1 day

1 visit (in-person)

Postoperative Follow-up

Safety and effectiveness outcomes are assessed at discharge, Day 7, and Day 30

4 weeks

3 visits (in-person)

Long-term Follow-up

Subjects in Arm 2 undergo 5-year follow-up to assess long-term oncological outcomes

5 years

Treatment Details

Interventions

• Endoscopic submucosal dissection using the ELS System

Trial Overview The trial tests the safety and effectiveness of the EndoQuest Endoluminal Surgical (ELS) System during transanal procedures for removing benign lesions from the rectum and sigmoid colon. The outcomes are assessed intraoperatively, at discharge, and on Days 7 and 30 post-operation.

Participant Groups

Group I: Arm 2 Experimental Treatment 1 Intervention

* 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.

Group II: Arm 1 Experimental Treatment 1 Intervention

* 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.

Who Is Running the Clinical Trial?

EndoQuest Robotics, Inc.

Lead Sponsor

Trials

1

Recruited

60+

References

1. Italy pubmed.ncbi.nlm.nih.gov

The clinical outcome of the endoscopic submucosal dissection of colonic polyps larger than 20 mm. A single medical study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility and learning curve of unsupervised colorectal endoscopic submucosal hydrodissection at a Western Center. [2021]

3. Australia pubmed.ncbi.nlm.nih.gov

Effective training system in colorectal endoscopic submucosal dissection. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Successful complete cure en-bloc resection of large nonpedunculated colonic polyps by endoscopic submucosal dissection: a meta-analysis and systematic review. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic submucosal dissection for superficial rectal tumors: prospective evaluation in France. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Endoscopic tissue shielding method with polyglycolic acid sheets and fibrin glue to cover wounds after colorectal endoscopic submucosal dissection (with video). [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical impact of endoscopic devices for colorectal endoscopic submucosal dissection. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Submucosal endoscopy with mucosal resection: a hybrid endoscopic submucosal dissection in the porcine rectum and distal colon. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Endoscopic submucosal dissection for colonic lesions: why and how should we do it? [2014]

10. Germany pubmed.ncbi.nlm.nih.gov

A colonoscopic overtube system that creates a 'therapeutic zone' and permits retraction facilitates endoscopic submucosal dissection, was associated with fewer deep bowel wall injuries and instrument exchanges, and required less lifting solution vs classic endoscopic submucosal dissection in an ex vivo bovine model. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

A novel multimodality endoscopic device for colonic submucosal dissection using a combination of bipolar radiofrequency and microwave modalities. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

In vitro porcine training model for colonic endoscopic submucosal dissection: an inexpensive and safe way to acquire a complex endoscopic technique. [2021]