Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Active, not recruiting

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT03626350
18-0046

Details and patient eligibility

About

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.

Enrollment

250 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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