Optimized Camera-based Patient Positioning in CT | NCT05135208

Studies
Optimized Camera-based Patient Positioning in CT

NCT05135208

Sponsor

Dr. Panagiota Manava

Status

Completed

Last Update Posted

Sep 1, 2022Actual

Enrollment

3,118Actual

Phase

Not provided

Conditions

Radiation Dosage

Interventions

Not provided

Countries

Germany

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

May 24, 2022Actual

Completion Date

May 24, 2022Actual

First Submitted Date

Nov 14, 2021

First Submission Date that Met QC Criteria

Nov 14, 2021

First Posted Date

Nov 26, 2021Actual

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

Aug 29, 2022

Last Update Posted Date

Sep 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Panagiota Manava, Dr. med. Panagiota Manava, MD, Attending Radiologist, Principal Invesigator, Paracelsus Medical UniversitySponsor-Investigator

Lead Sponsor

Dr. Panagiota ManavaOTHER

Collaborators

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the effect on radiation dose using intelligent camera positioning in comparison to manual positioning by the radiology assistant.

Detailed Description

The positioning of the patient at the beginning of every CT examination has an major influence on the image quality and especially on the respective effective patient dose in the CT scan. If the patient position is closer to the X-ray tube, the patient dose increases significantly and if the vertical patient position is chosen too far away from the X-ray tube, the applied dose decreases, but also the image quality.

In a retrospective observational study, patients were examined on the CT scanner Somatom X.Cite and divided into two groups, one group was with intelligent camera positioning and the other with manual positioning.

The patients received their CT scan at the Institute Radiology and Nuclear Medicine at the Nuremberg North Hospital strictly according to the clinical indication and without influence of the study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group		patients positioned with 3D camera
control group		patients positioned by experienced radiology assistants

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effective dose	the absorbed dose to different organs of the body	10 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Only patients with a clinical indication for a CT Scan

Exclusion Criteria:

renal insufficiency, manifest hyperthyroidism and pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

patients of a primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael M. Lell, Prof. Dr.	Department of Radiology and Nuclear Medicine, Klinikum Nuernberg, Paracelsus Medical University, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Radiology and Nuclear Medicine		Nuremberg	Bavaria	90419	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30306328	Background	Booij R, Budde RPJ, Dijkshoorn ML, van Straten M. Accuracy of automated patient positioning in CT using a 3D camera for body contour detection. Eur Radiol. 2019 Apr;29(4):2079-2088. doi: 10.1007/s00330-018-5745-z. Epub 2018 Oct 10.
24951205	Background	Kaasalainen T, Palmu K, Reijonen V, Kortesniemi M. Effect of patient centering on patient dose and image noise in chest CT. AJR Am J Roentgenol. 2014 Jul;203(1):123-30. doi: 10.2214/AJR.13.12028.