Wearable Technology in Endoscopy

July 14, 2023 updated by: Vinay Chandrasekhara, Mayo Clinic

A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy

Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, non-blinded, exploratory study to assess the accuracy and safety of wearable devices in the endoscopy suite with patients undergoing procedures using anesthesia assisted sedation using smart watches. We will also simultaneously perform an assessment of patient and provider preferences using narrative-driven, qualitative evaluation.

Study Type

Interventional

Enrollment (Actual)

292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults over 18 years of age.
  • Undergoing anesthesia-assisted endoscopic procedures.
  • Able to give appropriate consent to the study or have an appropriate representative to do so.

Exclusion Criteria:

  • Pregnancy.
  • Physical deformity, wound, or dressing preventing placement of a wearable device on the wrist.
  • Allergy to aluminum, nickel or acrylate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wearable technology in endoscopic gastrointestinal procedures with sedation
Subjects undergoing a endoscopic gastrointestinal procedure with sedation as part of standard of care will wear a consumer-facing wearable smart watch for the duration of the procedure.
Device: Consumer-facing wearable smart watch
Wearable watch technology that has the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and blood oxygen saturation.
Other Names:
  • Apple Watch Series 6
  • FitBit Versa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recorded Tachycardia Events
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of tachycardia events recorded as defined as heart rate > 100 bpm
Anesthesia Duration, approximately 30 to 45 minutes
Recorded Bradycardia Events
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of bradycardia events recorded as defined as heart rate < 60 bpm
Anesthesia Duration, approximately 30 to 45 minutes
Recorded Desaturation Events
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of desaturation events recorded as defined as peripheral O2 saturation <88%
Anesthesia Duration, approximately 30 to 45 minutes
Recorded Arrhythmia Events
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of arrhythmia events recorded
Anesthesia Duration, approximately 30 to 45 minutes
Recorded Tachypnea
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of tachypnea events recorded as defined as respiratory rate >18 breaths per minute
Anesthesia Duration, approximately 30 to 45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Vinay Chandrasekhara, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 4, 2021

First Submitted That Met QC Criteria

September 4, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-007738

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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