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Device

Hemostatic Agents for Kidney Cancer

N/A

Recruiting

Led By Arieh Shalhav, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a solid or cystic renal mass suspicious for malignancy by imaging with ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI)

Patients with bilateral kidneys or a solitary kidney, so long as these are native kidneys as opposed to a transplanted kidney

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial will determine if using hemostatic agents during robotic partial nephrectomy affects complication rates.

Who is the study for?

This trial is for adults with kidney tumors or cancer, who have a mass that looks like it might be malignant on an ultrasound, CT scan, or MRI. They should be scheduled for robotic-assisted laparoscopic partial nephrectomy and can have various common renal vessel configurations. People with bleeding disorders, previous kidney surgeries (except biopsy), renal transplants, or those on certain anticoagulants are not eligible.Check my eligibility

What is being tested?

The study is testing the necessity of hemostatic agents in robotic partial nephrectomy for treating kidney cancer. It compares outcomes between patients undergoing surgery with and without these blood-controlling substances to see if there's a difference in complications.See study design

What are the potential side effects?

While the trial itself does not introduce new medications that could cause side effects, surgical procedures may include risks such as bleeding, infection at the incision site, pain or discomfort from surgery, and potential impacts on kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney tumor is suspected to be cancerous based on an ultrasound, CT, or MRI.

Select...

I have my own kidneys, whether one or two, not a transplanted one.

Select...

I am scheduled for a specific kidney surgery using a robot.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

An absolute change in hemoglobin

Secondary outcome measures

Operating room parameters

Patients with a hospital stay over 30 days

Safety monitoring parameters: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1 (Hemostatic Agents Plus +)Experimental Treatment1 Intervention

Group II: Group 2 (Hemostatic Agents Negative -)Active Control1 Intervention

No Hemostatic Agent

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,599 Total Patients Enrolled

Arieh Shalhav, MDPrincipal InvestigatorUniversity of Chicago

Media Library

Hemostatic Agent (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04120805 — N/A

Kidney Cancer Research Study Groups: Group 2 (Hemostatic Agents Negative -), Group 1 (Hemostatic Agents Plus +)

Kidney Cancer Clinical Trial 2023: Hemostatic Agent Highlights & Side Effects. Trial Name: NCT04120805 — N/A

Hemostatic Agent (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04120805 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is enrollment progressing for this clinical research?

"Yes, the clinicaltrials.gov registry indicates that this is an ongoing trial with a start date of January 1st 2016 and most recently edited on June 3rd 2022. Currently, 178 individuals are being sought from one medical centre for participation in this study."

Answered by AI

Is this medical experiment accepting new participants?

"The clinical trial is accepting applicants, as the data that can be found on clinicaltrials.gov attests to. The study was first put up in January 2016 and recently updated on June 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

2016. "Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04120805.