NCT05647694

Brief Summary

The study will begin with an explanatory/training session where individuals with low vision will learn to use the V-NAV (Vortant NAVigation tool) indoor navigation app, and will have the opportunity to try it for a few representative tasks. The main activity includes a take-home trial, an extended unstructured period to emulate the post-purchase experience of users, during which participants will have the opportunity to use the V-NAV in their everyday lives. Data will be collected from the users to measure the relative advantage of V-NAV compared to the user's current indoor navigation method.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

November 29, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 29, 2022

Last Update Submit

November 21, 2024

Conditions

Keywords

blindness, indoor navigation

Outcome Measures

Primary Outcomes (1)

  • V-NAV effectiveness

    A measurement of user impressions as to the value of the V-NAV navigation aid. Use of e.g., PIADS survey.

    4 weeks

Secondary Outcomes (1)

  • V-NAV usability

    1 day

Study Arms (1)

V-NAV users

EXPERIMENTAL

Users who try the V-NAV for navigation tasks.

Other: V-NAV indoor navigation prototype

Interventions

Users will use the V-NAV prototype as an augmentation to their indoor navigation activities.

V-NAV users

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • AFB "visually impaired" definition, acuity 20/70 or worse or field loss of 140 degrees

You may not qualify if:

  • Any health condition that may affect safety of individual to participate
  • Any physical, mental, or behavioral impairment that would provide more than minimal risk or hindering ability to comprehend the purpose of the device or otherwise to be a potential user of the V-NAV hardware or app.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vortant Technologies

Weaverville, North Carolina, 28787, United States

Location

MeSH Terms

Conditions

BlindnessVision, Low

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philip R Schaefer, M.S.E

    Vortant Technologies, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The use of the app will not be masked.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Participants will compare the value of the prototype app to their previous navigational experience without the app.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 12, 2022

Study Start

January 1, 2025

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations