NCT07267533

Brief Summary

The purpose of the study is to assess the performance of Precise 3D Surview on CT 5300 and Incisive CT Scanners as compared with manual annotation by experienced CT technologists.

  • To evaluate the acceptance rate of the Auto 3D Planning Box compared with manual annotation by experienced CT technologists.
  • To evaluate the acceptance rate of the Auto Suggestion for Locator compared with manual annotation by experienced CT technologists.
  • To evaluate the acceptance rate of the Auto Planning for Truncated Anatomies (lung and liver) compared with manual annotation by experienced CT technologists.
  • To evaluate the acceptance rate of Auto Planning and Symmetry Correction for Tilted Head compared with manual annotation by experienced CT technologists.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jan 2026

Shorter than P25 for all trials

Status
not yet recruiting

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 Progress40%
Jan 2026Oct 2026

First Submitted

Initial submission to the registry

September 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

December 5, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 23, 2025

Last Update Submit

December 4, 2025

Conditions

Computed Tomography

Outcome Measures

Primary Outcomes (1)

  • Acceptance rate of the 3D Surview

    Reading session at 4 months

Eligibility Criteria

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

Adults

You may qualify if:

  • Subjects scanned by CT 5300 (K232491) and Incisive CT (K212441) according to the department standard of care clinical protocols.
  • Subjects age is over eighteen (18) years1.
  • Patients scanned in supine orientation.
  • Non-contrast CT scan
  • CT scan with standard resolution

You may not qualify if:

  • Subjects age is under or equal 18 years old
  • Patients are not scanned in supine orientation.
  • Contrast-enhanced CT scans.
  • CT scans with high resolution
  • Scans that are not completed due to technical difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2025

First Posted

December 5, 2025

Study Start

January 31, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

December 5, 2025

Record last verified: 2025-09