Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

Overview

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.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 12, 2023

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Procedure time
    • Time Frame: During procedure
    • Procedure time
  • Submucosal endoscopy technique and device used
    • Time Frame: During procedure
    • Submucosal endoscopy technique and device used

Participating in This Clinical Trial

Inclusion Criteria

1. Patients who will undergo submucosal endoscopy 2. Age >18 years Exclusion Criteria:

1. Age <18 years 2. Pregnancy 3. Coagulopathy (platelets less than 50, INR more than 1.8)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 89 Years

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor

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