ConMed Beamer Study
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|ClinicalTrials.gov Identifier: NCT04752670|
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : November 16, 2021
|Condition or disease|
|Gastrointestinal Neoplasms Achalasia Gastroparesis|
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 [Patient Registry]|
|Estimated Enrollment :||40 participants|
|Target Follow-Up Duration:||4 Weeks|
|Official Title:||Prospective Registry of Submucosal Endoscopic Procedures Performed by a Novel Electrosurgical Unit|
|Actual Study Start Date :||May 27, 2021|
|Estimated Primary Completion Date :||November 15, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- Technical Success rate [ Time Frame: 1 year ]Defined as the ability to perform the entire procedure using the ConMed Beamer electrosurgical system
- Procedure Time [ Time Frame: 1 year ]Determine length of time to perform procedure using ConMed Beamer electrosurgical system
- Adverse Events [ Time Frame: 1 year ]Intraprocedural AE such as bleeding or perforation
- Adverse Events [ Time Frame: 1 year ]Post procedural, post polypectomy, delayed bleeding or delayed perforation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752670
|Contact: Michael Mercado||7137983606||Michael.Mercado@bcm.edu|