NCT05704907

Brief Summary

To assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
terminated

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

January 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 4, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2024

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

January 17, 2023

Last Update Submit

September 20, 2024

Conditions

Gallstone

Keywords

abdominal and pelvic scanabdominal Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Gallstone detection using Dual Energy CT

    Number - size of gallstones

    Day 0

Secondary Outcomes (1)

  • Gallstone detection using reconstruction to conventionnal KeV.

    Day 0

Study Arms (1)

gallblader ultrasound

OTHER
Other: gallbladder ultrasound

Interventions

gallbladder ultrasoundOTHER

gallbladder ultrasound

gallblader ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient referred to the radiology department for an abdominal CT for abdominal pain, suspicion of cholangitis, cholecystitis, migration of stones, acute pancreatitis, suspicion of perforated ulcer in the emergency setting.
  • Non-objection of the subject to participate in the study
  • Affiliation to a French social security scheme or beneficiary of such a scheme.

You may not qualify if:

  • Cholecystectomy
  • Legal incapacity or limited legal capacity, legal safeguard
  • Pregnant women
  • Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25030, France

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Paul CALAME, MD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 30, 2023

Study Start

July 4, 2023

Primary Completion

September 19, 2024

Study Completion

September 19, 2024

Last Updated

September 23, 2024

Record last verified: 2024-09

Locations

FR(1)