A Study to Evaluate SimPull for Lateral Patient Transfer

NCT05856123 | Completed Results FDA Device

• 1 other identifier: 22-004929
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to test an investigational device called SimPull to see if it is a more efficient method of transferring a patient from one bed to another compared to that of current methods. The purpose of this research is to gather information on the safety and effectiveness of the SimPull device.

Conditions

Lateral Patient Transfer

Outcome Measures

Primary Outcomes (3)

• Time to Complete Lateral Transfer

  The average total time (minutes) it took to complete a lateral transfer.

  Baseline

• The Number of Staff Involved in a Transfer

  The average number of staff members engaged during transfers

  Baseline

• Average Weight of Participants

  The average weight (kilograms) of participants who underwent a lateral transfer

  Baseline

Secondary Outcomes (2)

• Clinician Satisfaction

  Baseline

• The Number of Survey Responses From Clinicians Who Indicated They Were Very Likely to Experience Injury During Transfers

  Baseline

Study Arms (3)

Group 1: Standard of Care Transfer

NO INTERVENTION

After cardiac catheterization lab or electrophysiology lab procedure, the subject will be moved from one bed to another using the current standard of practice lateral patient transfer methods by nursing staff.

Group 2: SimPull Device Transfer

EXPERIMENTAL

After cardiac catheterization lab or electrophysiology lab procedure, the subject will be moved from one bed to another using the SimPull device.

Device: SimPull Lateral Transfer Device

Group 3: Clinicians

ACTIVE COMPARATOR

Study clinicians complete a survey after conducting intervention or standard of care on participants.

Other: Survey

Interventions

SimPull Lateral Transfer Device DEVICE

Automated lateral transfer device

Group 2: SimPull Device Transfer

Survey OTHER

Complete Survey

Group 3: Clinicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring lateral transfer for an invasive cardiac procedure to and from gurney to exam table.
• Patients requiring lateral transfer for an invasive cardiac procedure to and from exam table to gurney.
• Patient does not have compound fractures or cervical fractures present.
• Patient does not have skin damage or open wounds to the dorsal cavity.
• Patient or legally authorized representative (LAR) must be able/present to sign consent.

You may not qualify if:

• Patients who do not require lateral transfer for an invasive cardiac procedure to and from gurney to exam table.
• Patients who do not require lateral transfer for an invasive cardiac procedure to and from exam table to gurney.
• Patient has compound fractures or cervical fractures present.
• Patient has skin damage or open wounds to the dorsal cavity.
• Patient or legally authorized representative (LAR) are unable/present to sign consent.

Sponsors & Collaborators

• Mayo Clinic: lead
• The Patient Company, LLC: collaborator

Study Sites (1)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

• Clinical Trials

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Deanna Covelli
• Organization: Mayo Clinic

covelli.deanna@mayo.edu

480-342-5284

Study Officials

• Deanna Covelli, MSN, RN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: November 16, 2023
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)