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OpenTrials
Completed

NCT Number: NCT04752670

ConMed Beamer Study

This is a prospective registry of all patients who endoscopic submucosal dissection (ESD), per-oral endoscopic myotomy (POEM) and gastric per-oral endoscopic myotomy (G-POEM) using ConMed Electrosurgical unit for submucosal Dissection at Baylor St Luke's Medical Center. Collected information includes; procedure technical success rate, duration, periprocedural complications and ease of use.

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Key information

About this study

Submucosal endoscopy is a novel subset of procedures which enables endoscopist to utilize the submucosal space to perform advanced endoscopic procedures. The submucosa is the third layer of the gastrointestinal wall and it is a potential space which is expandable upon injecting the submucosa with fluid. The expanded submucosa causes a significant lift which enable dissection of the submucosal space with the removal of the overlying polyp or early cancer. The submucosal space can be also utilized to create a longitudinal submucosal tunnel in the esophagus or the stomach wall which allows for performing lower esophageal sphincter or pyloric myotomy for the treatment of achalasia or Gastroparesis.

Currently, the most commonly performed submucosal endoscopy procedures are endoscopic submucosal dissection (ESD) for removal of early cancers or polyps throughout the gastrointestinal tract, Per-oral Endoscopic Myotomy (POEM) for treatment of achalasia, or Gastric Per-Oral Endoscopic myotomy for the treatment of Gastroparesis. All of the above procedures require a specialized electrosurgical unit (ESU) which generate high frequency current to help incision (cutting) of the mucosa and dissection (coagulation) of the submucosa. The ConMed Beamer is a novel ESU with tissue sensing property which expedites the process of submucosal dissection. The device is currently approved for clinical use in the US. The purpose of this study is to create registry for all submucosal endoscopy procedures performed using ConMed Beamer device at BSLMC with focus on clinical outcomes of the procedure including adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is ≥ 18 years old
  • Patient is capable of providing informed consent
  • Patient is referred for endoscopic submucosal dissection, per-oral endoscopic myotomy, or gastric per-oral endoscopic myotomy

Exclusion criteria

  • Patient is < 18 years old
  • Patient refused and/or unable to provide consent
  • Patient is a pregnant woman

Treatment and study plan

Primary outcomes

  1. Technical Success rate

    Time frame: 1 year

    Defined as the ability to perform the entire procedure using the ConMed Beamer electrosurgical system

Secondary outcomes

  1. Procedure Time

    Time frame: 1 year

    Determine length of time to perform procedure using ConMed Beamer electrosurgical system

  2. Adverse Events

    Time frame: 1 year

    Intraprocedural AE such as bleeding or perforation

  3. Adverse Events

    Time frame: 1 year

    Post procedural, post polypectomy, delayed bleeding or delayed perforation

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • CONMED Corporation

Registry information

Official study title

Prospective Registry of Submucosal Endoscopic Procedures Performed by a Novel Electrosurgical Unit

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2021
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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