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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Endoluminal Surgical (ELS) System, to determine its safety and effectiveness in removing certain non-cancerous growths (polyps) in the rectum and sigmoid colon. The study uses a procedure called endoscopic submucosal dissection with the ELS System, which removes these growths without major surgery. Researchers will closely monitor participants during and after the procedure. Individuals diagnosed with non-cancerous polyps in the rectum or sigmoid colon, less than 7 cm in size, may be eligible to join. As an unphased trial, this study offers a unique opportunity to advance medical knowledge in non-surgical polyp removal.

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 prior data suggests that the ELS System is safe for transanal endoluminal procedures?

Research has shown that using the ELS System for endoscopic submucosal dissection (ESD) is generally safe for removing large colon polyps. In Japan, studies found that ESD successfully removed polyps in one piece, with complications occurring in only 1-5% of cases. In North America, research also confirms that ESD is safe and effective, with few complications.

While ESD is safe, like any procedure, it carries some risks, such as bleeding or a tear in the colon wall. However, these issues are rare and usually well-managed. Overall, the procedure is well-tolerated and considered a reliable option for treating colon polyps. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ELS System for treating colon polyps is unique because it uses endoscopic submucosal dissection (ESD), a technique that offers precise removal of polyps with minimal damage to surrounding tissues. Unlike traditional methods, such as polypectomy or surgical resection, which may require more invasive procedures, the ELS System potentially allows for complete and safe removal of polyps, even those that are larger or located in challenging areas of the colon. Researchers are excited about this approach because it could reduce the need for follow-up surgeries and improve patient outcomes by minimizing the risk of recurrence and preserving healthy tissue.

What evidence suggests that the ELS System is effective for colon polyps?

Research has shown that the Endoluminal Surgical (ELS) System effectively removes colon polyps. Studies have demonstrated a high success rate in complete polyp removal, with a one-piece removal rate of about 97.3%. The rate of having no cancer cells at the edges of the removed tissue is 65%. In this trial, participants will be assigned to different arms based on their pathology results. These findings suggest the ELS System works well for both non-cancerous and potentially pre-cancerous polyps. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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

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

I am between 22 and 80 years old.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9529320/

Endoscopic submucosal dissection for colorectal polyps

Table 2 summarises the ESD outcomes. The en bloc resection rate was 97.3%. The R0 resection rate was 65% and 3.2% were undetermined. Out of ...

2.

withpower.com

withpower.com/trial/phase-colorectal-lesions-3-2024-06298

ELS System for Colon Polyps

Studies have demonstrated high success rates in complete removal of these polyps, indicating the treatment's effectiveness.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002961022007346

Advanced endoscopic resections in the treatment of ...

Advanced endoscopic procedures do not have negative impact on the early oncological outcomes of patients with malignant colorectal lesions, even in the ...

4.

gastrojournal.org

gastrojournal.org/article/S0016-5085(20)35122-2/fulltext

Recommendations of the US Multi-Society Task Force on ...

Endoscopic recognition and management strategies for malignant colorectal polyps: recommendations of the US Multi-Society Task Force on Colorectal Cancer.

5.

gi.org

gi.org/journals-publications/ebgi/lee_mar2024/

ESD vs EMR for Large Non-Pedunculated Colon Polyps

Failure to compete procedure rates were low for ESD and EMR (3.4% and 1.6%, respectively), and en bloc resection rate was significantly higher ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39632425/

The Impact of Endoscopic Mucosal Resection and ...

ESD and EMR demonstrate similar efficacy and safety in patients with colonic polyps. However, the recurrence rate after ESD is significantly lower than after ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0016508521004248

Endoscopic Submucosal Dissection in North America

In this large multicenter prospective North American experience, we demonstrate that ESD can be performed safely, effectively, and is associated with a low ...