NCT06384079

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
54mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Sep 2024Nov 2030

First Submitted

Initial submission to the registry

February 19, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 24, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Expected
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

February 19, 2024

Last Update Submit

November 22, 2024

Conditions

Ureteral Stricture

Outcome Measures

Primary Outcomes (1)

  • Ureteral stricture length measured by antegrade or retrograde pyelogram

    2 weeks and 6 weeks post procedure

Secondary Outcomes (1)

  • Ureteral Stricture Quality will be graded as either narrowed or obliterated segment.

    2 weeks and 6 weeks post procedure

Study Arms (1)

Endoscopic Evaluation

Antegrade and retrograde pyelogram will be completed prior to definitive ureteral repair

Procedure: Antegrade and retrograde pyelogram

Interventions

Antegrade and retrograde pyelogramPROCEDURE

Participation in the study will guarantee that participants will receive this procedure.

Endoscopic Evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects over 18 years of age undergoing surgery to fix the ureter.

You may qualify if:

  • \>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

You may not qualify if:

  • \<18 years of age
  • Inability to provide informed consent
  • Members of vulnerable patient populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Central Study Contacts

Emily Ji

CONTACT

312-695-8146emily.ji@nm.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2024

First Posted

April 25, 2024

Study Start

September 24, 2024

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2030

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)