ConMed Beamer Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04752670

Enrollment

Registered

2021-02-12

Start date

2021-05-27

Completion date

2022-05-01

Last updated

2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia, Gastrointestinal Neoplasms, Gastroparesis

Keywords

Endoscopic Submucosal Dissection, Per-Oral Endoscopic Myotomy (POEM), Gastric Per-Oral Endoscopic Myotomy (G-POEM)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Procedure Time	1 year	Determine length of time to perform procedure using ConMed Beamer electrosurgical system
Adverse Events	1 year	Intraprocedural AE such as bleeding or perforation

Countries

United States

Outcome results