Actively Recruiting
Advanced Endo-therapeutic Procedure Registry-based Observational Study
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-03-05
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating advanced therapeutic endoscopy procedures to provide minimally invasive treatment options for gastrointestinal (GI) diseases such as Zenker Diverticulum, colon polyps, and colorectal cancer. This registry-based observational study at the Centre Hospitalier de l'Université de Montréal aims to improve the quality of advanced endotherapeutic practices by collecting and analyzing data to identify both low-quality and high-quality procedures. The study includes various advanced endoscopic procedures such as Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), polypectomy quality assessment for colorectal adenomas/polyps, Radio Frequency Ablation (RFA), Argon Plasma Ablation (APC), and Per Oral Endoscopic Myotomy (POEM). These procedures are recorded prospectively in a protected electronic registry. Each technique involves specific methods, including mucosal resection, submucosal dissection, thermal ablation, and endoscopic myotomy under general anesthesia with expert operators and specialized equipment. Participants undergo these advanced endotherapeutic procedures with data collected on outcomes such as complication rates, completeness of tissue resection, bleeding, perforation, and recurrence over 6 to 18 months. The study monitors technical skills of endoscopists and assesses quality of life after treatment. Safety is tracked through severe complication rates within 14 days post-procedure. This long-term follow-up supports efforts to enhance therapeutic endoscopy quality and patient care.
CONDITIONS
Brief Title
Advanced Endo-therapeutic Procedure : Registry-based Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Presenting for an elective advanced therapeutic endoscopy (ESD, EMR, advanced polypectomy, POEM or Zenker treatment)
- Signed informed consent form
You will not qualify if you...
- Unable to understand the trial or without consent
- Having a bleeding disorder (coagulopathy)
- Poor general health (American Society of Anesthesiologists class greater than three)
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo advanced therapeutic endoscopy procedures such as EMR, ESD, RFA, APC, or POEM as part of the registry-based observational study.
1 visit (in-person)
Duration - 6 to 18 months
Participants are monitored for outcomes including complications, completeness of resection, recurrence, and quality of life over time.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire de Montréal (CHUM)
Montreal, Quebec, Canada
Actively Recruiting
Research Team
D
Daniel von Renteln, MD, PhD
S
Samira Hanin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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