HealthyNCT05044104

Wearable Technology in Endoscopy

A study testing Consumer-facing wearable smart watch in people with Healthy, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Consumer-facing wearable smart watch
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 292 participants
Where: 1 siteUnited States
Study dates: 11 Jan 2022to 1 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Healthy
Being tested: Consumer-facing wearable smart watch
Keywords: Gastrointestinal Endoscopic Procedure with sedation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Consumer-facing wearable smart watchDevice
Also called Apple Watch Series 6, FitBit Versa
Wearable watch technology that has the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and blood oxygen saturation.

Study groups in NCT05044104
Study group	Role	What they receive
Wearable technology in endoscopic gastrointestinal procedures with sedation	Experimental	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. Receives: Device: Consumer-facing wearable smart watch

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 20221 Sep 2022

First posted14 Sep 2021
Study start11 Jan 2022
Primary completion1 Sep 2022
Study completion1 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05044104
Sponsor's protocol ID: 21-007738
Status last verified: Jul 2023
First submitted: 4 Sep 2021
Last updated: 20 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy
ClinicalTrials.gov ID: NCT05044104
Acronym / sponsor ID: 21-007738
Conditions: Healthy
Keywords: Gastrointestinal Endoscopic Procedure with sedation
Study type: Interventional
Recruitment status: Completed
Enrolment: 292 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 11 Jan 2022 (actual)
Primary completion: 1 Sep 2022 (actual)
Study completion: 1 Sep 2022 (actual)
First posted: 14 Sep 2021 (actual)
Results: Posted 20 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Wearable technology in endoscopic gastrointestinal procedures with sedation	Experimental	Device: Consumer-facing wearable smart watchSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Consumer-facing wearable smart watchAlso: Apple Watch Series 6, FitBit VersaWearable watch technology that has the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and blood oxygen saturation.	Device	Wearable technology in endoscopic gastrointestinal procedures with sedation

Primary outcome

Recorded Tachycardia Events
Time frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of tachycardia events recorded as defined as heart rate > 100 bpm
Recorded Bradycardia Events
Time frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of bradycardia events recorded as defined as heart rate < 60 bpm
Recorded Desaturation Events
Time frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of desaturation events recorded as defined as peripheral O2 saturation <88%
Recorded Arrhythmia Events
Time frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of arrhythmia events recorded
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

Results and safety

Results posted to the registry on 20 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Undergoing Gastrointestinal Endoscopy With Sedation	292	292

Primary outcome: Recorded Tachycardia Events

Time frame: Anesthesia Duration, approximately 30 to 45 minutes. Number. Unit: Events

Measure	Patients Undergoing Gastrointestinal Endoscopy With Sedation n = 292
Anesthesia Monitoring	9
Smartwatch	3
Smartwatch Accessories	22

Primary outcome: Recorded Bradycardia Events

Time frame: Anesthesia Duration, approximately 30 to 45 minutes. Number. Unit: Events

Measure	Patients Undergoing Gastrointestinal Endoscopy With Sedation n = 292
Anesthesia Monitoring	119
Smartwatch	67
Accessories	33

Primary outcome: Recorded Desaturation Events

Time frame: Anesthesia Duration, approximately 30 to 45 minutes. Number. Unit: events

Measure	Patients Undergoing Gastrointestinal Endoscopy With Sedation n = 292
Anesthesia Monitoring	91
Smartwatch	0
Smartwatch Accessories	71

Primary outcome: Recorded Arrhythmia Events

Time frame: Anesthesia Duration, approximately 30 to 45 minutes. Number. Unit: events

Measure	Patients Undergoing Gastrointestinal Endoscopy With Sedation n = 292
Anesthesia Monitoring	1
Smartwatch	0
Smartwatch accessories	0

Adverse events

Time frame: Adverse events were collected from baseline to end of study participation for a total of approximately 14 days on all participants.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Undergoing Gastrointestinal Endoscopy With Sedation	0 of 292 (0%)	0 of 292 (0%)	0 of 292

Limitations and caveats (from the sponsor): Limited number of arrhythmia events; Inconsistent accuracy of device reading; Device fit differed between patients

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vinay Chandrasekhara, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Consumer-facing wearable smart watch in people with Healthy, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recorded Tachycardia Events (time frame: Anesthesia Duration, approximately 30 to 45 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05044104.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.