ConMed Beamer Study

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752670
• Other study ID #: H-49160
• Status: Completed
• Start date: May 27, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Gastroparesis

Locations

Country	Name	City	State
United States	Baylor St. Lukes Medical Center (BSLMC)	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	ConMed Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success rate	Defined as the ability to perform the entire procedure using the ConMed Beamer electrosurgical system	1 year
Secondary	Procedure Time	Determine length of time to perform procedure using ConMed Beamer electrosurgical system	1 year
Secondary	Adverse Events	Intraprocedural AE such as bleeding or perforation	1 year
Secondary	Adverse Events	Post procedural, post polypectomy, delayed bleeding or delayed perforation	1 year