Peritoneal SclerosisNCT05652049
Using New Ultrasound Techniques to Assess Peritoneal Fibrosis in Peritoneal Dialysis Patients
An observational study of Peritoneal Sclerosis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Explore the role of new ultrasound techniques in the assessment of peritoneal fibrosis and encapsulating peritoneal sclerosis in peritoneal dialysis patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Sclerosis
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End-stage renal diseases（ESRD） patients on PD
Who may be able to join
- ESRD patients on PD
- PD duration ≤12 months or ≥10 years
- Age between 18-75years
Who cannot join
- Refusing to sign up informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200001
About this study
Official title: 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
- Conditions
- Peritoneal Sclerosis
- Medical subject headings
- Peritoneal Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| short-term peritoneal dialysis | the time of treatment of peritoneal dialysis less 12 months | |
| long-term peritoneal dialysis | the time of treatment of peritoneal dialysis more than 10 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
parietal peritoneal fibrosis
Ultrasonography evaluates parietal peritoneal fibrosis, including parameters such as thickness, stiffness, elasticity, and blood supply.
Measured: the 1 day when being recruited
Secondary outcomes (1)
encapsulting peritoneal sclerosis
Ultrasonography assesses for encapsulting peritoneal sclerosis.
Measured: the 1 day when being recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal SclerosisStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Na Jiang, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652049
- Sponsor's protocol ID
- new ultrasound technology
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study Using New Ultrasound Techniques to Assess Peritoneal Fibrosis and Encapsulating Peritoneal Sclerosis in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT05652049
- Acronym / sponsor ID
- new ultrasound technology
- Conditions
- Peritoneal Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Explore the role of new ultrasound techniques in the assessment of peritoneal fibrosis and encapsulating peritoneal sclerosis in peritoneal dialysis patients
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-term peritoneal dialysis | – | –the time of treatment of peritoneal dialysis less 12 months |
| long-term peritoneal dialysis | – | –the time of treatment of peritoneal dialysis more than 10 years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-stage renal diseases（ESRD） patients on PD
Key inclusion criteria (3 listed)
- ESRD patients on PD
- PD duration ≤12 months or ≥10 years
- Age between 18-75years
Key exclusion criteria (1 listed)
- Refusing to sign up informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
encapsulting peritoneal sclerosis
Time frame: the 1 day when being recruited
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Sclerosis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Na Jiang, MD (+86-21-53882014, Jiangjiang198311@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parietal peritoneal fibrosis (time frame: the 1 day when being recruited). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.