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Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks

NCT06258486 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-26

No results posted yet for this study

Summary

Goal is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy.

Conditions

Interventions

DRUG

ICG injection

Patient will have a green dye (ICG) injected into the lymph node to better visualize non-sealed leaks in order to pre-emptively seal any lymphatic leaks.

OTHER

Non-Injection/Control

No ICG injection

PROCEDURE

Prostatectomy with pelvic lymph node dissection

Robotic assisted prostatectomy with pelvic lymph node dissection

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • David Finley, MD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Drug
Yes

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Diseases

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 NCT06258486 on ClinicalTrials.gov