AR Ruler to Improve Safety and Clinical Workflow During P... | NCT05399875

Studies
AR Ruler to Improve Safety and Clinical Workflow During PICC Placement

NCT05399875

Sponsor

University of Pennsylvania

Status

Active, not recruiting

Last Update Posted

Sep 11, 2025Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Insertion of Peripherally Inserted Central Catheter

Interventions

Augmented reality virtual ruler

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2022Actual

Primary Completion Date

Feb 24, 2025Actual

Completion Date

Jun 30, 2026Estimated

First Submitted Date

May 26, 2022

First Submission Date that Met QC Criteria

May 26, 2022

First Posted Date

Jun 1, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2025

Last Update Posted Date

Sep 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the utility of an augmented reality virtual ruler during placement of peripherally inserted central catheters.

Detailed Description

After being informed about the study, patients who give consent will have their peripheral inserted central catheter placed by a physician wearing mixed reality smart glasses. The mixed reality smart glasses will have an application that allows the physician to measure distances with their hands. This application will be used to measure the appropriate length for which to trim the central catheter.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Augmented reality virtual ruler	Experimental	Patient's in this arm will have their physician use an augmented reality virtual ruler to measure catheter length during catheter placement.	Other: Augmented reality virtual ruler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Augmented reality virtual ruler	Other	Use of augmented reality virtual ruler to measure catheter length	Augmented reality virtual ruler

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with appropriate catheter tip location	Catheter tip location will be evaluated by the treating physician on x-ray	End of procedure

Secondary Outcomes

Measure	Description	Time Frame
Radiation dose	Total radiation dose of the procedure will be captured from the fluoroscopy machine	End of procedure
Procedure time	Procedure time to complete catheter placement will be captured from the radiology information system.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for a non-emergent peripherally inserted central catheter placement in Interventional Radiology
Over 18 years

Exclusion Criteria:

Undergoing an emergent peripherally inserted central catheter placement
Younger than 18 years old

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ali H Dhanaliwala, MD, PhD	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will not be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided