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NCT03626350 · ClinicalTrials.gov registry record
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
A clinical trial of Gastroparesis and Esophageal Obstruction, sponsored by University of Colorado, Denver.
- Active
- Registry status
- 250
- Enrollment target
- 1
- Study location
NCT03626350 is a study of Gastroparesis and Esophageal Obstruction that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 250 participants, below the 296-participant average among 44 other Gastroparesis trials with a reported enrollment target (16% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03626350, a study of Gastroparesis and Esophageal Obstruction, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2018-06-12 |
| Est. Completion | 2025-06-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03626350
The ClinicalTrials.gov registry entry for NCT03626350 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 296-participant average among 44 other Gastroparesis trials with a reported enrollment target (16% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Gastroparesis appearing as the primary indexed condition, and to 0 interventions.
NCT03626350 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT03626350 about?
NCT03626350 is a clinical study titled "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 gu...
What is the current status of trial NCT03626350?
This trial is currently active not recruiting. The enrollment target is 250 participants. The study started on 2018-06-12. Estimated completion is 2025-06-12.
What conditions does trial NCT03626350 study?
This clinical trial studies the following conditions: Gastroparesis, Esophageal Obstruction, Gastrointestinal Neoplasia, Hirschsprung's Disease, Spastic Esophageal Disorders.
Who is sponsoring clinical trial NCT03626350?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03626350 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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