HydronephrosisNCT00585767
Functional, Dynamic, and Anatomic MR Urography
An observational study of Hydronephrosis, run by University of California, Davis.
Trial summary
This is a clinical feasibility study to assess the value of MR imaging for obtaining functional, dynamic and anatomical information in a comprehensive imaging protocol in subjects having obstructive uropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydronephrosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to May 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed with obstructive uropathy
Who may be able to join
- Males or females 18 years of age or older.
- All female patients of childbearing potential must agree to use a medically accepted method of contraception at the time of the study.
- Patients must have the ability to understand the requirements of the study, provide written and informed consent to participate, and agree to abide by the study requirements.
- Patients who have known or suspected hydronephrosis or patients with solitary kidneys.
Who cannot join
- Patients with known or suspected hypersensitivity to gadolinium-based agents.
- Patients who are pregnant or lactating.
- Patients with a condition that is a contraindication to MRI (e.g., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other conditions that would preclude patient proximity to a strong external magnetic field).
- Patients with a recent history of hemolytic anemia, sickle cell anemia or other hemoglobinopathy.
- Patients with a history of significant claustrophobia.
- Patients with impaired renal function based on 24-hr urine collection (creatinine clearance <10 ml/min or serum creatinine >1.8 mg/dl)
About this study
This is a clinical feasibility study to assess the value of MR imaging for obtaining functional, dynamic and anatomical information in a comprehensive imaging protocol in subjects having obstructive uropathy.
- Conditions
- Hydronephrosis
- Keywords
- Hydronephrosis
- Medical subject headings
- Hydronephrosis
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 |
|---|---|---|
| 1 | Patients with two kidneys | |
| 2 | Patients with solitary kidney |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startApr 2001
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydronephrosisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Katzburg, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585767
- Sponsor's protocol ID
- 200311391
- Status last verified
- May 2017
- First submitted
- 26 Dec 2007
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional, Dynamic, and Anatomic MR Urography
- ClinicalTrials.gov ID
- NCT00585767
- Acronym / sponsor ID
- 200311391
- Conditions
- Hydronephrosis
- Keywords
- Hydronephrosis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2001
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 3 Jan 2008 (estimated)
- 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.
This is a clinical feasibility study to assess the value of MR imaging for obtaining functional, dynamic and anatomical information in a comprehensive imaging protocol in subjects having obstructive uropathy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with two kidneys |
| 2 | – | –Patients with solitary kidney |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with obstructive uropathy
Key inclusion criteria (4 listed)
- Males or females 18 years of age or older.
- All female patients of childbearing potential must agree to use a medically accepted method of contraception at the time of the study.
- Patients must have the ability to understand the requirements of the study, provide written and informed consent to participate, and agree to abide by the study requirements.
- Patients who have known or suspected hydronephrosis or patients with solitary kidneys.
Key exclusion criteria (6 listed)
- Patients with known or suspected hypersensitivity to gadolinium-based agents.
- Patients who are pregnant or lactating.
- Patients with a condition that is a contraindication to MRI (e.g., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other conditions that would preclude patient proximity to a strong external magnetic field).
- Patients with a recent history of hemolytic anemia, sickle cell anemia or other hemoglobinopathy.
- Patients with a history of significant claustrophobia.
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Related trials for Hydronephrosis
Not yet recruiting
Safety and Efficacy of Ultrasound-Guided Percutaneous Nephrostomy in Oncology Patients
Obstructive Uropathy, Hydronephrosis
Active, not recruitingEarly Phase 1
Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery
Hydronephrosis, Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant
RecruitingObservational study
Long-term Safety of UAS-assisted vs Sheathless RIRS in Non-prestented Patients
Renal Stone Disease, Ureteral Stricture
Not yet recruiting
Integrating an AI-Driven Hydronephrosis Decision-Making Tool
Hydronephrosis, Hydronephrosis Congenital
RecruitingObservational study
Shear Wave Elastography for Evaluation of Hydronephrosis in Pregnancy
Hydronephrosis, Pregnancy
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.
Richard Katzburg, MD principal investigator
University of California, Davis
Questions about this trial
What is this clinical trial studying?
An observational study of Hydronephrosis, run by University of California, Davis.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 30 May 2017.