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NCT05044104

Wearable Technology in Endoscopy

Completed NA Results posted Last updated 20 July 2023
What this trial tests

NA trial testing Consumer-facing wearable smart watch in Healthy in 292 participants. Completed in 1 September 2022.

Timeline
11 January 2022
Primary endpoint
1 September 2022
1 September 2022

Quick facts

Lead sponsorMayo Clinic
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment292
Start date11 January 2022
Primary completion1 September 2022
Estimated completion1 September 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recorded Tachycardia Events Primary · Anesthesia Duration, approximately 30 to 45 minutes

Number of tachycardia events recorded as defined as heart rate \> 100 bpm

Anesthesia Monitoring
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation9
Smartwatch
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation3
Smartwatch Accessories
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation22
Recorded Bradycardia Events Primary · Anesthesia Duration, approximately 30 to 45 minutes

Number of bradycardia events recorded as defined as heart rate \< 60 bpm

Anesthesia Monitoring
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation119
Smartwatch
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation67
Accessories
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation33
Recorded Desaturation Events Primary · Anesthesia Duration, approximately 30 to 45 minutes

Number of desaturation events recorded as defined as peripheral O2 saturation \<88%

Anesthesia Monitoring
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation91
Smartwatch
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation0
Smartwatch Accessories
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation71
Recorded Arrhythmia Events Primary · Anesthesia Duration, approximately 30 to 45 minutes

Number of arrhythmia events recorded

Anesthesia Monitoring
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation1
Smartwatch
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation0
Smartwatch accessories
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation0
Recorded Tachypnea Primary · Anesthesia Duration, approximately 30 to 45 minutes

Number of tachypnea events recorded as defined as respiratory rate \>18 breaths per minute

Anesthesia Monitoring
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation29
Smartwatch
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation0
Smartwatch accessories
GroupValue95% CI
Patients Undergoing Gastrointestinal Endoscopy With Sedation0

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05044104.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing