Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
|ClinicalTrials.gov Identifier: NCT03626350|
Recruitment Status : Enrolling by invitation
First Posted : August 13, 2018
Last Update Posted : January 18, 2020
To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia.
The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria.
A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.
|Condition or disease|
|Gastrointestinal Neoplasia Hirschsprung's Disease Esophageal Obstruction Gastroparesis Spastic Esophageal Disorders Zenker's Diverticulum|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||250 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy|
|Actual Study Start Date :||June 12, 2018|
|Estimated Primary Completion Date :||June 12, 2023|
|Estimated Study Completion Date :||June 12, 2025|
- Technical and clinical success in performing submucosal endoscopy [ Time Frame: baseline to one year ]Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.
- Adverse Events [ Time Frame: baseline to one year ]as defined by published ASGE criteria
- Procedure time [ Time Frame: During procedure ]Procedure time
- Submucosal endoscopy technique and device used [ Time Frame: During procedure ]Submucosal endoscopy technique and device used
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626350
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|