MedTrace Logo

Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy

NCT03528057 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-07-05

No results posted yet for this study

Summary

The aim of this study is to evaluate whether Hemostatic Agents (HA) make a significant clinical difference in patient outcomes when used for Robotic-Assisted Laparoscopic Partial Nephrectomy (RALPN). The result of this trial will determine whether HAs are necessary for use during RALPN or if they can be omitted from the surgical tools available during this procedure. This study has a direct clinical implication on a patient's outcomes following RALPN, specifically whether patients will have better, worse, or unchanged outcomes with RALPN if HAs are used.

Conditions

  • Robotic-Assisted Laparoscopic Partial Nephrectomy
  • Hemostatic Agents
  • Renal Malignant Tumor

Interventions

DEVICE

Hemostat

Hemostatic agents, if used at all during surgery, will be applied laparoscopically into the tumor bed to stop bleeding. The type of hemostat will be decided by the surgeon according to the anatomy of the tumor bed.

Sponsors & Collaborators

Principal Investigators

  • Robert Nadler, MD · Professor of Urology, Feinberg School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2019-05-31
Completion
2020-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03528057 on ClinicalTrials.gov