Ureteral StrictureNCT06384079
Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery
An observational study of Ureteral Stricture, run by Northwestern University at 1 site in United States.
Trial summary
Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stricture
- What is being tested?
- Antegrade and retrograde pyelogram
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2024to Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subjects over 18 years of age undergoing surgery to fix the ureter.
Who may be able to join
- >18 years of age
- Undergoing ureteral reconstruction surgery for ureteral stricture with conversion of an indwelling stent to a percutaneous nephrostomy tube for ureteral rest
- Willing to sign informed consent form
- Able to read and understand informed consent form
Who cannot join
- <18 years of age
- Inability to provide informed consent
- Members of vulnerable patient populations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Emily Ji, 312-695-8146, emily.ji@nm.org
Ziho Lee, MD
About this study
Official title: Study to Assess Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery
Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery.
- Conditions
- Ureteral Stricture
- Being tested
- Antegrade and retrograde pyelogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antegrade and retrograde pyelogramProcedure or surgery
Participation in the study will guarantee that participants will receive this procedure.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Evaluation | Antegrade and retrograde pyelogram will be completed prior to definitive ureteral repair Receives: Procedure: Antegrade and retrograde pyelogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteral stricture length measured by antegrade or retrograde pyelogram
Measured: 2 weeks and 6 weeks post procedure
Secondary outcomes (1)
Ureteral Stricture Quality will be graded as either narrowed or obliterated segment.
Measured: 2 weeks and 6 weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start24 Sep 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StrictureStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziho Lee, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384079
- Sponsor's protocol ID
- STU00219828
- Status last verified
- Nov 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT06384079
- Acronym / sponsor ID
- STU00219828
- Conditions
- Ureteral Stricture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 25 Apr 2024 (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.
Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Evaluation | – | Procedure: Antegrade and retrograde pyelogramAntegrade and retrograde pyelogram will be completed prior to definitive ureteral repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects over 18 years of age undergoing surgery to fix the ureter.
Key inclusion criteria (4 listed)
- >18 years of age
- Undergoing ureteral reconstruction surgery for ureteral stricture with conversion of an indwelling stent to a percutaneous nephrostomy tube for ureteral rest
- Willing to sign informed consent form
- Able to read and understand informed consent form
Key exclusion criteria (3 listed)
- <18 years of age
- Inability to provide informed consent
- Members of vulnerable patient populations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antegrade and retrograde pyelogramParticipation in the study will guarantee that participants will receive this procedure. | Procedure or surgery | Endoscopic Evaluation |
Primary outcome
Ureteral stricture length measured by antegrade or retrograde pyelogram
Time frame: 2 weeks and 6 weeks post procedure
1 secondary outcome
Ureteral Stricture Quality will be graded as either narrowed or obliterated segment.
Time frame: 2 weeks and 6 weeks post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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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.
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 Ureteral Stricture, run by Northwestern University at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 26 Nov 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Ji (312-695-8146, emily.ji@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ureteral stricture length measured by antegrade or retrograde pyelogram (time frame: 2 weeks and 6 weeks post procedure). 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 26 Nov 2024.