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Bladder Perfusion of Plasma-Activated Saline for Bladder Cancer

NCT07272603 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-12-09

No results posted yet for this study

Summary

This preliminary clinical study evaluates the safety and initial efficacy of a novel therapy called Plasma-Activated Saline Solution (PASS) for bladder cancer patients. The study involves a one-week course of PASS administered via bladder infusion in five pre-surgical patients, using imaging and pathology analyses to assess tumor shrinkage and cancer cell death, while closely monitoring for any adverse reactions to explore the therapy's future potential.

Conditions

  • Bladder (Urothelial, Transitional Cell) Cancer

Interventions

DRUG

Plasma-Activated Saline Solution (PASS) Bladder Instillation

This intervention is distinguished by its unique mechanism of action, which utilizes physically-activated normal saline infused with reactive oxygen and nitrogen species (RONS) generated by non-thermal plasma, creating a potent yet transient cytotoxic solution that is administered locally.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • benkang shi · Qilu Hospital of Shandong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-02-15
Completion
2026-02-15

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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 NCT07272603 on ClinicalTrials.gov