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Use of SPY Fluorescent Angiography to Reduce Ureteroenteric Stricture Rate Following Urinary Diversion

NCT05022199 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-08-26

No results posted yet for this study

Summary

Ureteroenteric anastomotic stricture is a well-known complication of urinary diversion which occurs in 4-25% of patients. Recent study has yielded that radiation is a significant risk factor for development of ureteroenteric stricture. The goal of this study is to determine whether intraoperative use of SPY fluorescent angiography during urinary diversion reduces rate of ureteroenteric stricture.

This study will include 215 patients who have undergone urinary diversion over the past 5 years as historic controls and compare ureteroenteric stricture rates to a prospective cohort of patients in whom intraoperative SPY fluorescent angiography was used at the time of urinary diversion to assess the anastomotic perfusion. This will include injection of ICG intravenously as well as utilization of the SPY device to assess ureteral perfusion before and after ureteroenteric anastomosis. Based on power analysis, this study will require approximately 50 patients in our prospective group to detect a clinically significant difference of 5% between groups. Data analysis plan includes the use of chi square test for comparison of stricture rates between groups. Clinical outcomes will be followed prospectively, with no amendment to standard follow-up per physician.

Conditions

  • Ureteral Obstruction
  • Stricture Ureter

Interventions

DEVICE

SPY fluorescent angiography

This group has had SPY fluorescent angiography used intraoperatively during urinary diversion. To be compared with historic controls who did not.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-12-31
Completion
2023-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022199 on ClinicalTrials.gov