ALgorithms Adapted From Remote Monitoring

NCT ID: NCT05782140

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-20

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mayo Clinic Rochester Surgical Patients

Mayo Clinic Watch Device

Mayo Clinic Watch Device

Intervention Type DEVICE

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

Interventions

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Mayo Clinic Watch Device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 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.

Exclusion Criteria

* \<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.
* Subjects enrolled in another device or drug study does not necessarily preclude them from participating in this study. Please check with the PI for inclusion if the subject is on another device or drug study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Janani S. Reisenauer

Assistant Professor of Surgery, College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janani Reisenauer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karlyn Pierson, MAN, RN

Role: CONTACT

507-538-1960

Facility Contacts

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Karlyn Pierson, RN, MAN

Role: primary

507-538-1960

Related Links

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Other Identifiers

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22-003308

Identifier Type: -

Identifier Source: org_study_id

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