Back to resultsOptimization of Spleen VCTE Examinations With FibroScan
Primary Purpose
Spleen; Fibrosis
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FibroScan examination (S)
FibroScan examination (M)
FibroScan examination (XL)
FibroScan examination (Standard M)
Sponsored by
About this trial
This is an interventional other trial for Spleen; Fibrosis focused on measuring FibroScan, Vibration Control Transient Elastography, Spleen Stiffness Measurement
Eligibility Criteria
Inclusion Criteria:
- Adult or pediatric patient able to give written informed consent (parents/legal tutors in case of minor patients),
- Patient affiliated to the healthcare system
- Adult or children patient followed for a liver disease, with or without splenomegaly and having a spleen to skin distance (SSD) measurement performed during the screening ultrasound exam.
Exclusion Criteria:
- Vulnerable patient- other than pediatric patients
- Patients with ascites
Sites / Locations
- University Medical Center Rotterdam
- Regional Institute of Gastroenterology and Hepatology "Octavian Fodor" (IRGH)Recruiting
- Hospital Puerta de Hierro MajadahondaRecruiting
- Hospital Universitario La PazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1a: SSD<15mm and with splenomegaly
Group 1b: SSD<15mm and without splenomegaly
Group 2a : 15<SSD<25mm and with splenomegaly
Group 2b : 15<SSD<25mm and without splenomegaly
Group 3a: SSD≥25mm and with splenomegaly
Group 3b: SSD≥25mm and without splenomegaly
Arm Description
Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly.
Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly.
Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly.
Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly.
Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly.
Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly.
Outcomes
Primary Outcome Measures
Success rate of the spleen stiffness measurement (SSM) exam with the XL probe, defined with at least 8 valid measurements after the exam quality control
The success rate is calculated with the number of valid measurements vs the total measurements done by the operator for every exam. The FibroScan will automatically analyze the measurement and based on some validity criteria will define the measurement as "valid" (will lead to a reliable SSM measurement) or "invalid" (will lead to a non-reliable SSM measurement).
Secondary Outcome Measures
Success rate of the spleen stiffness measurement (SSM) exam with the S probe, defined with at least 8 valid measurements after the exam quality control.
The success rate is calculated with the number of valid measurements vs the total measurements done by the operator for every exam. The FibroScan will automatically analyze the measurement and based on some validity criteria will define the measurement as "valid" (will lead to a reliable SSM measurement) or "invalid" (will lead to a non-reliable SSM measurement).
Success rate of the spleen stiffness measurement (SSM) exam with the optimized M probe, defined with at least 8 valid measurements after the exam quality control.
The success rate is calculated with the number of valid measurements vs the total measurements done by the operator for every exam. The FibroScan will automatically analyze the measurement and based on some validity criteria will define the measurement as "valid" (will lead to a reliable SSM measurement) or "invalid" (will lead to a non-reliable SSM measurement).
Change of the applicability with the Spleen Targeting Tool (STT) and the automatic depth adaptation mode enabled.
This will be tested with unilateral Wilcoxon signed rank test comparing success rates with and without STT and with and without automatic depth adaptation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05122416
Brief Title
Optimization of Spleen VCTE Examinations With FibroScan
Official Title
Optimization of Spleen VCTE Examinations With FibroScan
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Echosens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an European, prospective, interventional, and multicenter clinical investigation which main objective is to develop a spleen examination dedicated to overweight or obese patients and assess its applicability. It will take place in 4 sites (1 site in the Netherlands, 2 sites in Spain and 1 site in Romania) to include a total of 500 patients (adults and children).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spleen; Fibrosis
Keywords
FibroScan, Vibration Control Transient Elastography, Spleen Stiffness Measurement
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be 6 different groups of patients depending on the spleen to skin distance and the presence or absence of splenomegaly. Every patient in every group will do an ultrasound and 2 FibroScan exams. The differences between Group 1 (1a and 1b), Group 2 (2a and 2b) and Group 3 (3a and 3b) are the probes that will be used to do the FibroScan.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1a: SSD<15mm and with splenomegaly
Arm Type
Experimental
Arm Description
Patients with a Spleen to Skin Distance less than 15mm and who present a splenomegaly.
Arm Title
Group 1b: SSD<15mm and without splenomegaly
Arm Type
Experimental
Arm Description
Patients with a Spleen to Skin Distance less than 15mm and who does not present a splenomegaly.
Arm Title
Group 2a : 15<SSD<25mm and with splenomegaly
Arm Type
Experimental
Arm Description
Patients with a Spleen to Skin Distance between 15 and 25 mm and who present a splenomegaly.
Arm Title
Group 2b : 15<SSD<25mm and without splenomegaly
Arm Type
Experimental
Arm Description
Patients with a Spleen to Skin Distance between 15 and 25 mm and who does not present a splenomegaly.
Arm Title
Group 3a: SSD≥25mm and with splenomegaly
Arm Type
Experimental
Arm Description
Patients with a Spleen to Skin Distance higher than 25 mm and who present a splenomegaly.
Arm Title
Group 3b: SSD≥25mm and without splenomegaly
Arm Type
Experimental
Arm Description
Patients with a Spleen to Skin Distance higher than 25 mm and who does not present a splenomegaly.
Intervention Type
Device
Intervention Name(s)
FibroScan examination (S)
Intervention Description
A FibroScan examination with the Exploratory S probe.
Intervention Type
Device
Intervention Name(s)
FibroScan examination (M)
Intervention Description
A FibroScan examination with the Optimized M probe.
Intervention Type
Device
Intervention Name(s)
FibroScan examination (XL)
Intervention Description
A FibroScan examination with the Exploratory XL probe.
Intervention Type
Device
Intervention Name(s)
FibroScan examination (Standard M)
Intervention Description
A FibroScan examination with the Standard M probe.
Primary Outcome Measure Information:
Title
Success rate of the spleen stiffness measurement (SSM) exam with the XL probe, defined with at least 8 valid measurements after the exam quality control
Description
The success rate is calculated with the number of valid measurements vs the total measurements done by the operator for every exam. The FibroScan will automatically analyze the measurement and based on some validity criteria will define the measurement as "valid" (will lead to a reliable SSM measurement) or "invalid" (will lead to a non-reliable SSM measurement).
Time Frame
At baseline visit
Secondary Outcome Measure Information:
Title
Success rate of the spleen stiffness measurement (SSM) exam with the S probe, defined with at least 8 valid measurements after the exam quality control.
Description
The success rate is calculated with the number of valid measurements vs the total measurements done by the operator for every exam. The FibroScan will automatically analyze the measurement and based on some validity criteria will define the measurement as "valid" (will lead to a reliable SSM measurement) or "invalid" (will lead to a non-reliable SSM measurement).
Time Frame
At baseline visit
Title
Success rate of the spleen stiffness measurement (SSM) exam with the optimized M probe, defined with at least 8 valid measurements after the exam quality control.
Description
The success rate is calculated with the number of valid measurements vs the total measurements done by the operator for every exam. The FibroScan will automatically analyze the measurement and based on some validity criteria will define the measurement as "valid" (will lead to a reliable SSM measurement) or "invalid" (will lead to a non-reliable SSM measurement).
Time Frame
At baseline visit
Title
Change of the applicability with the Spleen Targeting Tool (STT) and the automatic depth adaptation mode enabled.
Description
This will be tested with unilateral Wilcoxon signed rank test comparing success rates with and without STT and with and without automatic depth adaptation.
Time Frame
At baseline visit
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult or pediatric patient able to give written informed consent (parents/legal tutors in case of minor patients),
Patient affiliated to the healthcare system
Adult or children patient followed for a liver disease, with or without splenomegaly and having a spleen to skin distance (SSD) measurement performed during the screening ultrasound exam.
Exclusion Criteria:
Vulnerable patient- other than pediatric patients
Patients with ascites
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Llorca
Phone
+33144827850
Email
anne.llorca@echosens.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Caroline Gourmelon
Phone
+33144827850
Email
marie-caroline.gourmelon@echosens.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert de Knegt, PhD
Organizational Affiliation
University Medical Center Rotterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Rotterdam
City
Rotterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert de Knegt, PhD
Email
r.deknegt@erasmusmc.nl
Facility Name
Regional Institute of Gastroenterology and Hepatology "Octavian Fodor" (IRGH)
City
Cluj-Napoca
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horia Stefanescu, Dr
Email
drhstefanescu@gmail.com
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Luis Calleja, PhD
Email
joseluis.calleja@uam.es
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Romero, Dr
Email
mromerop@salud.madrid.org
12. IPD Sharing Statement
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Optimization of Spleen VCTE Examinations With FibroScan
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