Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752670
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2021-02-09
Brief Title:
ConMed Beamer Study
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Prospective Registry of Submucosal Endoscopic Procedures Performed by a Novel Electrosurgical Unit
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Lukes 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None