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Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors

NCT03238664 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-01-02

No results posted yet for this study

Summary

This randomized pilot trial studies how well robot-assisted laparoscopic high-intensity focused ultrasound works compared to robot-assisted radical cystectomy for thermal ablation of muscle invasive cells in patients with bladder tumors. Laparoscopic high-intensity focused ultrasound uses high frequency sound waves to deliver a strong beam to a specific part of the tumor and may lower the number of tumor cells released into the blood stream compared to radical cystectomy.

Conditions

  • Infiltrating Bladder Urothelial Carcinoma
  • Stage II Bladder Urothelial Carcinoma
  • Transitional Cell Carcinoma

Interventions

PROCEDURE

Biopsy

Undergo biopsy of bladder tumor

DEVICE

High-Intensity Focused Ultrasound Ablation

Undergo laparoscopic HIFU

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Radical Cystectomy

Undergo RARC

DEVICE

Ultrasonography

Undergo CEUS

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Inderbir Gill, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2019-01-22
Completion
2020-01-22
FDA Device
Yes

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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 NCT03238664 on ClinicalTrials.gov