Trials / Active Not Recruiting

Active Not RecruitingNCT03626350

Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

Status: Active Not Recruiting
Phase: —
Study type: Observational
Enrollment: 250 (actual)

Sponsor: University of Colorado, Denver · Academic / Other
Sex: All
Age: 18 Years – 89 Years
Healthy volunteers: —

Summary

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.

Conditions

Timeline

Start date: 2018-06-12
Primary completion: 2025-06-12
Completion: 2025-06-12
First posted: 2018-08-13
Last updated: 2024-05-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03626350. Inclusion in this directory is not an endorsement.