NCT05782140

Brief Summary

Through the aid of remote monitoring and early symptom detection, a patient's response to stress and normalization to their individual baseline can better contribute towards algorithms which are predictive of clinical decline.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 24, 2023

Last Update Submit

February 20, 2026

Conditions

Keywords

Remote Monitoring

Outcome Measures

Primary Outcomes (1)

  • Rate of Compliance of Remote Monitoring

    Determine the feasibility of remote monitoring for preoperative assessment and postoperative follow up by evaluation of rate of compliance of physiological monitoring data and patinet recorded logs.

    Pre-operative to 15 days post discharge.

Secondary Outcomes (1)

  • Correlation of Compensatory Reserve Algorithm

    Pre-operative to 15 days post discharge.

Study Arms (1)

Mayo Clinic Rochester Surgical Patients

Mayo Clinic Watch Device

Device: Mayo Clinic Watch Device

Interventions

Mayo Clinic remote monitoring platform (Omni) that utilizes a wearable device with integrated physiological monitoring capabilities.

Mayo Clinic Rochester Surgical Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing surgery in the Mayo Clinic Rochester Department of Surgery.

You may qualify if:

  • years and older
  • Scheduled to undergo surgery resulting in a complex recovery as evaluated by the treating Department of Surgery surgeon. This includes but is not limited to the following inpatient elective surgery procedures: esophagectomy, pancreatectomy, major liver resections, open vascular surgery, lower extremity bypass, colectomy, and complex pulmonary resections (lobes and above).
  • Subjects are committed to daily exercise as outlined in the protocol.

You may not qualify if:

  • \<18 years of age
  • Subject is pregnant
  • Subject is dismissed from the hospital to a nursing home or long term care facility.
  • Subject cannot commitment to daily exercise as outlined in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Janani Reisenauer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery, College of Medicine

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 23, 2023

Study Start

February 20, 2023

Primary Completion

February 25, 2025

Study Completion

February 25, 2025

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations