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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03626350
Other study ID # 18-0046
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 12, 2018
Est. completion date June 12, 2025

Study information

Verified date May 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 250
Est. completion date June 12, 2025
Est. primary completion date June 12, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility 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 Design


Locations

Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Adverse Events as defined by published ASGE criteria baseline to one year
Secondary Procedure time Procedure time During procedure
Secondary Submucosal endoscopy technique and device used Submucosal endoscopy technique and device used During procedure
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