Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

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 Overview

• Status: Active, not recruiting
• Conditions: Gastroparesis; Zenker's Diverticulum; Hirschsprung's Disease; Esophageal Obstruction; Gastrointestinal Neoplasia; Spastic Esophageal Disorders

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

A prospective database/registry of patients undergoing submucosal endoscopic procedures will be formed. Women and minorities will be included as they are frequently found to have indications for which submucosal endoscopic procedures may be indicated.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical and clinical success in performing submucosal endoscopy	Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.	baseline to one year
Adverse Events	as defined by published ASGE criteria	baseline to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Procedure time	During procedure
Submucosal endoscopy technique and device used	Submucosal endoscopy technique and device used	During procedure

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Estimated): June 12, 2025
• Study Completion (Estimated): June 12, 2025

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Congenital Abnormalities; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Diverticular Diseases; Paralysis; Digestive System Abnormalities; Megacolon; Diverticulum, Esophageal; Gastroparesis; Diverticulum; Hirschsprung Disease; Esophageal Diseases; Zenker Diverticulum
• Other Study ID Numbers: 18-0046

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No