Feasibility of HISA During TURBT for NMIBC

Part of paid clinical trials in Charleston, West Virginia.

Sponsor
CAMC Health System
Study ID
NCT07817173
Status
Not Yet Recruiting

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Conditions

  • Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy)
  • Bladder Cancer
  • Bladder Cancer (BC)
  • Non-Muscle Invasive Bladder Carcinoma
  • Non-Muscle Invasive Bladder Neoplasms
  • Non-muscle Invasive Bladder Cancer
  • Non-muscle Invasive Bladder Cancer (NMIBC)
  • Transurethral Resection of Bladdertumors
  • Transurethral Resection of the Bladder

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • HISA — DEVICE
    The intervention arm (HISA) will be treated in the same way as the control arm with the addition of administering hyperthermic (42.0 ± 2°C) intravesical saline during the TURBT. Bladder irrigation with 1g of gemcitabine will be delivered in the immediate postoperative setting. The Thermaclear FluidSmart Fluid management system (Stryker, MI) will be used to administer and irrigate the bladder with normothermic or hyperthermic intravesical saline during the TURBT.

Study Details

The goal of this prospective pilot study is to evaluate the safety and feasibility of using heated saline during bladder tumor surgery in patients with non-muscle invasive bladder cancer. The main questions it aims to answer are: Can heated saline be given during bladder tumor removal surgery safely? Does using heated saline keep the bladder tumor from coming back? Researchers will compare the heated saline to room temperature saline to see if the heated saline works to prevent the bladder tumor from coming back. Participants will: * Have heated saline or room temperature saline during bladder tumor surgery * Visit the clinic at 2 weeks, 3 and 6 months after bladder tumor surgery * Complete questionnaires about quality of their life and symptoms before and after surgery * Provide urine samples to test your urine at each visit before and after surgery * To have a cystoscopy to check your bladder for tumors

Key Dates

First listed
Sep 14, 2026
Start date
Aug 15, 2026
Status verified
Jul 2026
Primary completion
Feb 29, 2028
Completion
May 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: No HISA
    The control arm (no HISA) will consist of standard intraoperative care including bladder irrigation with normothermic saline during TURBT.
  • Experimental: HISA
    The intervention arm (HISA) will be treated in the same way as the control arm with the addition of administering hyperthermic (42.0 ± 2°C) intravesical saline during the TURBT.

Primary Outcome Measure

Patient Recruitment [ Time Frame: one year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Charleston Area Medical Center Memorial HospitalCharlestonWest Virginia25304
Jacqueline C Fannin, PhD
[email protected]
6062250344
[email protected]
Michael G Stencel, DO (PRINCIPAL_INVESTIGATOR)
Jacqueline C Fannin, PhD (SUB_INVESTIGATOR)

Find similar trials in Charleston, WV

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By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Charleston Area Medical Center Memorial Hospital· Charleston, WV

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