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Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626350
Recruitment Status : Enrolling by invitation
First Posted : August 13, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date August 2, 2018
First Posted Date August 13, 2018
Last Update Posted Date January 18, 2020
Actual Study Start Date June 12, 2018
Estimated Primary Completion Date June 12, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2018)
  • Technical and clinical success in performing submucosal endoscopy [ Time Frame: baseline to one year ]
    Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.
  • Adverse Events [ Time Frame: baseline to one year ]
    as defined by published ASGE criteria
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 14, 2018)
  • Procedure time [ Time Frame: During procedure ]
    Procedure time
  • Submucosal endoscopy technique and device used [ Time Frame: During procedure ]
    Submucosal endoscopy technique and device used
Original Secondary Outcome Measures
 (submitted: August 7, 2018)
Procedure time and submucosal endoscopy technique and device used [ Time Frame: During procedure ]
Procedure time and submucosal endoscopy technique and device used
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
Official Title Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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.
Condition
  • Gastrointestinal Neoplasia
  • Hirschsprung's Disease
  • Esophageal Obstruction
  • Gastroparesis
  • Spastic Esophageal Disorders
  • Zenker's Diverticulum
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: August 7, 2018)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 12, 2025
Estimated Primary Completion Date June 12, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03626350
Other Study ID Numbers 18-0046
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Colorado, Denver
Verification Date January 2020