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h-APC Margin Ablation for Colon Polyps (h-APC_EMR Trial)
N/A
Recruiting
Led By Daniel von Renteln
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient referred for endoscopic resection of all colorectal polyps non-pedunculated equal or greater 20 mm
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days after the index emr
Awards & highlights
h-APC_EMR Trial Summary
This trialtested a technique to reduce recurrence of colon adenomas after surgery. It found post-EMR ablation of resection margins using soft coagulation and h-APC reduced recurrence to 5%.
Who is the study for?
This trial is for patients needing removal of large, non-pedunculated colorectal polyps (≥20 mm) and who can provide consent. It's open to all ethnicities and races but excludes those with invasive carcinoma in the study polyp, prior partial EMR, certain lesion types, severe health issues (ASA class>3), pregnant or breastfeeding individuals, inflammatory bowel disease sufferers, emergency cases, coagulopathy or poor bowel preparation.Check my eligibility
What is being tested?
The trial tests Hybrid Argon Plasma Coagulation (h-APC) after Endoscopic Mucosal Resection (EMR) for colon adenomas. h-APC aims to reduce recurrence by lifting the mucosa with saline injection before ablation. This follows evidence that margin ablation post-EMR significantly lowers adenoma recurrence rates.See study design
What are the potential side effects?
While h-APC is designed to be safe with a low risk of side effects due to its cushioning technique during ablation, potential risks may include discomfort at the procedure site and rare complications like bleeding or perforation.
h-APC_EMR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am referred for a procedure to remove large non-pedunculated polyps in my colon.
h-APC_EMR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days after the index emr
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days after the index emr
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate adenoma recurrence rate
Evaluate complete adenoma eradication rates
Secondary outcome measures
Completeness of thermal ablation of polyp resection margin
To evaluate the uniformity of the margins and bases of resection after hAPC ablation following an EMR.
h-APC_EMR Trial Design
1Treatment groups
Experimental Treatment
Group I: Group treatment h-APC and EMRExperimental Treatment1 Intervention
Standard endoscopic mucosal resection (EMR) technique will be used for primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection is used as per the current standard of care using a contrast agent and a lifting agent (e.g. NaCl 0.9% or Voluven). Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp. Electrocautery snare technique is facilitated using standard microprocessor controlled electrocautery (e.g. ERBE VIO Endocut 3-1-6). Ablation of the margin after visibly complete removal of the polyp is routinely applied. For thermal ablation hybrid APC (Erbe Hybrid APC) will be applied using standard settings on the margin and resection base. Once resection and thermal ablation is considered complete the mucosal defect can be closed with clips or another preventative measure applied to reduce the risk for post-polypectomy bleeding.
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Who is running the clinical trial?
Dr John levenickUNKNOWN
Dr Alessandro RepiciUNKNOWN
Penn State UniversityOTHER
355 Previous Clinical Trials
125,457 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- People of all ethnicities and races are eligible to participate.I am undergoing an emergency colonoscopy.I have inflammatory bowel disease.My overall health is poor.I have had a partial EMR before.I am referred for a procedure to remove large non-pedunculated polyps in my colon.My polyp has been confirmed to be cancerous through a biopsy.My condition involves ulcerated depressed lesions.You are pregnant or currently breastfeeding.I need a specific procedure to remove part of my stomach before another treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group treatment h-APC and EMR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this study currently open?
"The hunt for participants is ongoing, as indicated by the records on clinicaltrials.gov. The study was first uploaded to this database on August 26th 2019 and saw its last update occur on November 28th 2022."
Answered by AI
Is this research trial open to individuals 45 years of age and older?
"The requirements for patient enrollment stipulate that they must be aged 18-89. For younger or elder individuals respectively, there are 192 and 1572 clinical trials available to them."
Answered by AI
How many participants are allowed to partake in this research endeavor?
"Affirmative. The particulars on clinicaltrials.gov demonstrate that this investigation is actively seeking participants, with the first posting of the trial occuring August 26th 2019 and a most recent update taking place November 28th 2022. 300 individuals are needed from 1 medical centre for enrollment in this study."
Answered by AI
Is there a requirement to qualify for enrolling in this experiment?
"This medical trial is seeking 300 individuals aged 18 to 89 with colorectal carcinoma. Patients must be of any ethnicity or race and have been referred for endoscopic resection of all colorectal polyps non-pedunculated equal or greater 20 mm, in addition to providing written informed consent."
Answered by AI
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