- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05652049
Using New Ultrasound Techniques to Assess Peritoneal Fibrosis in Peritoneal Dialysis Patients
December 14, 2022 updated by: Na Jiang, Shanghai Jiao Tong University School of Medicine
An Exploratory Study Using New Ultrasound Techniques to Assess Peritoneal Fibrosis and Encapsulating Peritoneal Sclerosis in Peritoneal Dialysis Patients
Explore the role of new ultrasound techniques in the assessment of peritoneal fibrosis and encapsulating peritoneal sclerosis in peritoneal dialysis patients
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
210
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Na Jiang, MD
- Phone Number: +86-21-53882014
- Email: Jiangjiang198311@163.com
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200001
- Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
End-stage renal diseases(ESRD) patients on PD
Description
Inclusion Criteria:
- ESRD patients on PD
- PD duration ≤12 months or ≥10 years
- Age between 18-75years
Exclusion Criteria:
- Refusing to sign up informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
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short-term peritoneal dialysis
the time of treatment of peritoneal dialysis less 12 months
|
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long-term peritoneal dialysis
the time of treatment of peritoneal dialysis more than 10 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
parietal peritoneal fibrosis
Time Frame: the 1 day when being recruited
|
Ultrasonography evaluates parietal peritoneal fibrosis, including parameters such as thickness, stiffness, elasticity, and blood supply.
|
the 1 day when being recruited
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
encapsulting peritoneal sclerosis
Time Frame: the 1 day when being recruited
|
Ultrasonography assesses for encapsulting peritoneal sclerosis.
|
the 1 day when being recruited
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
December 8, 2022
First Submitted That Met QC Criteria
December 14, 2022
First Posted (Estimate)
December 15, 2022
Study Record Updates
Last Update Posted (Estimate)
December 15, 2022
Last Update Submitted That Met QC Criteria
December 14, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- new ultrasound technology
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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