ConMed Beamer Study

Completed

• Conditions: Gastroparesis; Achalasia; Gastrointestinal Neoplasms

• Registration Number: NCT04752670
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-12
• Study Start: 2021-05-27
• Primary Completion: 2022-03-02
• Status Verified: 2022-05
• Study Completion: 2022-05-01
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical Success rate	1 year	Defined as the ability to perform the entire procedure using the ConMed Beamer electrosurgical system

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 year	Post procedural, post polypectomy, delayed bleeding or delayed perforation
Procedure Time	1 year	Determine length of time to perform procedure using ConMed Beamer electrosurgical system

Trial Locations

Locations (1)

Baylor St. Lukes Medical Center (BSLMC); 🇺🇸 Houston, Texas, United States