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Endoluminal Surgical System

ELS System for Rectal Lesion

N/A
Waitlist Available
Led By Todd Wilson, MD
Research Sponsored by ColubrisMX
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 22-80 years
Lesion size is ≤ 7 cm, with size determined according to the American College of Gastroenterology (ACGE) and the American College of Colon and Rectal Surgeons (ACCRS) guidelines as the dimension of the lesion that is greatest in extent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is designed to study the safety and effectiveness of a new medical system called the ELS System. The ELS System is used in transanal endoluminal procedures, which are procedures that are performed through the anus and involve the rectum and distal colon (the last part of the colon). The trial will be conducted at multiple centers and will involve training surgeons and their teams to use the ELS System.

Who is the study for?
This trial is for adults aged 22-80 with a BMI ≤ 40 kg/m2 and an ASA score ≤ 3, who have benign rectal lesions like adenomas or polyps that are no larger than 7 cm and located within 17 cm of the anal verge. Participants must not be on blood thinners that can't be stopped before surgery, have untreated infections, cancerous lesions, severe illnesses, inflammatory bowel disease, or a history of colorectal cancer treatment.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the ColubrisMX Endoluminal Surgical (ELS) System in removing rectal lesions without full surgery. It's also checking how well surgeons can learn to use this system. The ELS System will be used in transanal endoluminal procedures up to a certain distance from the anal opening.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include typical surgical complications such as infection at the site of surgery, bleeding during or after procedure, pain associated with recovery and possible damage to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 80 years old.
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My lesion is 7 cm or smaller, as measured by specific guidelines.
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I have a non-cancerous growth within 17 cm of my anal opening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complication-Free Rate (percent)
En Bloc Resection Rate (percent)
R0 Resection Rate (percent)
Secondary outcome measures
Adverse Events (percent)
Clinical Laboratory Assessments
Conversion-Free Rate (percent)
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Robotically assisted transanal endoluminal resection of rectal lesionExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

ColubrisMXLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Todd Wilson, MDPrincipal InvestigatorUniversity of Texas
Erik Askenasy, MDPrincipal InvestigatorUniversity of Texas

Media Library

ColubrisMX ELS System (Endoluminal Surgical System) Clinical Trial Eligibility Overview. Trial Name: NCT04651764 — N/A
Rectal Lesion Research Study Groups: Robotically assisted transanal endoluminal resection of rectal lesion
Rectal Lesion Clinical Trial 2023: ColubrisMX ELS System Highlights & Side Effects. Trial Name: NCT04651764 — N/A
ColubrisMX ELS System (Endoluminal Surgical System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04651764 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies for participation in this clinical trial?

"To join this clinical trial, participants should have adenoma and be between the ages of 22 to 80 years old. The research team is seeking 26 individuals for their study."

Answered by AI

Are there any current openings for participation in this trial?

"According to the details present on clinicaltrials.gov, recruitment for this particular medical trial has concluded. The study was first posted in mid-September 2020 and edited last at the end of August 2021-- however, there are still 95 other trials actively seeking participants."

Answered by AI

Does this research endeavor cater to participants younger than sixty?

"To participate in this medical trial, enrollees must be between 22 and 80 years old. Conversely, there are 8 studies that cater to minors under the age of 18 and 92 for elderly patients over 65."

Answered by AI

What objectives does this research endeavor seek to accomplish?

"This medical trial, which is slated to last around 30 days, will principally evaluate the Complication-Free Rate (CFR) of patients. The secondary endpoints are Adverse Events (AE), Conversion-Free Rate (CFR), and Disease Free Survival rate for subjects with a cancer diagnosis only. Data concerning AE severity and its relation to the study drug will be collected pre-, post-, during treatment; each adverse event shall be classified from mild to life threatening in scope. Finally, Cancer survivors' 5 year follow up according to NCCN rectal cancer guidelines should give us an estimate of Disease Free Survival%."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
2020. "Transanal Resection of Rectal Lesions With the ColubrisMX ELS System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04651764.
~6 spots leftby Apr 2025
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