Feasibility of HISA During TURBT for NMIBC

NCT07817173 | Not Yet Recruiting FDA Device

• 2 other identifiers: 25-1357U54GM104942
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Patient Recruitment

  The primary outcome will be patient recruitment. Patient recruitment will be the number of patients recruited divided by the total number of eligible patients.

  one year

• Protocol Adherence for HISA Treatment

  Protocol adherence will be assessed per case. Full adherence is defined as: (1) assigned saline used; (2) temperature maintained at 42.0 ± 2.0°C for ≥80% of intended exposure; (3) delivery of hyperthermic saline occurred during the specified operative window, and (4) postoperative instillation of 1g gemcitabine for 60 minutes.

  one year

Secondary Outcomes (1)

• Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates

  Three years

Other Outcomes (4)

• Overall Cancer-related Quality of Life and General Treatment Effects

  From TURBT to 6 months after TURBT

• Recurrence of NMIBC

  From time of TURBT to 6 months after TURBT

• Survival of NMIBC Patients

  From time of TURBT to 6 months after TURBT

Study Arms (2)

No HISA

NO INTERVENTION

The control arm (no HISA) will consist of standard intraoperative care including bladder irrigation with normothermic saline during TURBT.

HISA

EXPERIMENTAL

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.

Device: HISA

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.

HISA

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients
• Age from 18 to 89 years old
• Visual diagnosis of a papillary tumor(s) ≤ 3 cm
• Transurethral resection of bladder tumor (TURBT)
• Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2
• Glomerular filtration rate (GFR) ≥ 30 mL/min

You may not qualify if:

• Ages less than 18 years of age
• Pregnant women
• Prisoners
• Patients with evidence of distant metastasis
• Patients with histologically confirmed high-risk NMIBC prior to and after TURBT
• Patients with prior carcinoma is situ diagnosis
• Patients with an active infection defined as documented urinary tract infection based on preoperative urine analysis or urine culture
• Immunosuppression defined as a patient with leukopenia or taking any active immunosuppressive medication
• Patients that had an intraoperative perforation during TURBT
• Patients participating in another clinical trial with this urologic cancer diagnosis
• Postoperative bladder instillation failure defined as the inability to deliver and maintain the planned volume of instilled fluid within the bladder for at least 30 minutes

Sponsors & Collaborators

• CAMC Health System: lead
• West Virginia Clinical and Translational Science Institute: collaborator

Study Sites (1)

Charleston Area Medical Center Memorial Hospital

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Michael G Stencel, DO

  CAMC Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael G Stencel, DO

CONTACT

1-304-388-5280; michael.stencel@vandaliahealth.org

Jacqueline C Fannin, PhD

CONTACT

1-304-388-9923; jacqueline.fannin@vandaliahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to what arm they were randomized to until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: September 14, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): May 31, 2030
• Last Updated: September 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)