Actively Recruiting

Age: 18Years +
All Genders
ID04117100

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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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Frequently Asked Questions

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