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Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection

NCT04147182 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-11-04

No results posted yet for this study

Summary

Hypertonic saline at the concentration of 3% (hypersel) has been injected for years into echinococcal cysts to kill live scolices, and is also known to kill suspended cells by means of a steep osmotic gradient and the investigators postulate that perioperative intravesical instillation of hypersel for patients with low grade bladder cancer is safe and may be active against shedded and suspended tumor cells and thus may decrease recurrence risk.

Conditions

  • TCC

Interventions

DRUG

Hypertonic Saline 3%

3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents.

Sponsors & Collaborators

  • Dan Leibovici

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-02
Primary Completion
2019-07-03
Completion
2020-11-03

Countries

  • Israel

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 NCT04147182 on ClinicalTrials.gov