Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-31 @ 10:01 AM
Study NCT ID:
NCT05044104
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2021-09-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Wearable Technology in Endoscopy
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: