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Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery

NCT01602991 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-09-24

No results posted yet for this study

Summary

This study aims to determine that this new technology, nasopharyngoendoscopy, is just as effective in diagnosing problems as the current gold standard.

Conditions

Interventions

PROCEDURE

clinic-based nasopharyngoendoscopy

The study intervention is an in-office transnasal esophagoscopy. It is done in clinic, immediately after deciding the patient requires investigation of their upper gastrointestinal tract and the patient signs consent. The nasopharynx and oral pharynx is topically anesthetized. Since flexible scope is much thinner than a standard endoscopy, there is no requirement for intravenous sedation and thus, no requirement for specialized monitoring, nursing or recovery units. The procedure takes approximately 10 minutes. This study will be using the E.G. Scan II System.

PROCEDURE

Standard Endoscopy

The control procedure is standard endoscopy. Endoscopy will be performed as per standard clinic practice. It is typically scheduled within 2 weeks of seeing the patient in clinic. The patient will be required to fast for 6 hours prior to the procedure. In most cases, patients will require intravenous sedation. If sedation is used, the patient will be required to take the day off work and have someone drive them home. This is the standard treatment for patients who present with upper gastrointestinal symptoms post-bariatric surgery. Patients who choose not to participate in this study will still undergo endoscopy as per standard clinical practice.

Sponsors & Collaborators

  • Vantage Endoscopy

    collaborator UNKNOWN

  • Dennis Hong MD

    lead OTHER

Principal Investigators

  • Dennis Hong, MD · McMaster University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01602991 on ClinicalTrials.gov