ConMed Beamer Study

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Neoplasms; Gastroparesis; Achalasia

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor St. Lukes Medical Center (BSLMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients referred for an ESD, POEM or GPOEM satisfying all eligibility criteria will be eligible for the study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success rate	Defined as the ability to perform the entire procedure using the ConMed Beamer electrosurgical system	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time	Determine length of time to perform procedure using ConMed Beamer electrosurgical system	1 year
Adverse Events	Intraprocedural AE such as bleeding or perforation	1 year
Adverse Events	Post procedural, post polypectomy, delayed bleeding or delayed perforation	1 year

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: CONMED Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Endoscopic Submucosal Dissection; Per-Oral Endoscopic Myotomy (POEM); Gastric Per-Oral Endoscopic Myotomy (G-POEM)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastroparesis
• Other Study ID Numbers: H-49160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a prospective single-center registry study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No