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Evaluation of Modified Bite-Block for Invasive Imaging Procedures

NCT04236297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-04-15

No results posted yet for this study

Summary

The purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography procedures in patients who are either sedated or under general anesthesia.

These dental protector devices are class I devices which are exempt from the FDA 510(k) premarket notification requirements.

Conditions

  • Bite Block

Interventions

DEVICE

bite block

Physicians performing transesophageal echocardiogram in patients under sedation or general anesthesia will use either standard or modified bite block.

Sponsors & Collaborators

Principal Investigators

  • Srdjan Jelacic, MD · University of Washington

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2020-08-30
Completion
2020-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04236297 on ClinicalTrials.gov