Gastroparesis Clinical Trial
Official title:
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
Verified date | May 2024 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
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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