Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

NCT03626350 | Active Not Recruiting

• 1 other identifier: 18-0046
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Gastrointestinal Neoplasia; Hirschsprung's Disease; Esophageal Obstruction; Gastroparesis; Spastic Esophageal Disorders; Zenker's Diverticulum

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Procedure time

  During procedure

• Submucosal endoscopy technique and device used

  During procedure

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who will undergo submucosal endoscopy
• Age \>18 years

You may not qualify if:

• Age \<18 years
• Pregnancy
• Coagulopathy (platelets less than 50, INR more than 1.8)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hirschsprung Disease; Airway Obstruction; Gastroparesis; Zenker Diverticulum

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diverticulum, Esophageal; Diverticulum; Diverticular Diseases; Gastroenteritis; Pathological Conditions, Anatomical

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 13, 2018
• Study Start: June 12, 2018
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

US (1)