Bladder CancerNCT07817173
Feasibility of HISA During TURBT for NMIBC
A study testing HISA in people with Bladder Cancer and Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy), run by CAMC Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Bladder Cancer, Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy), Non-muscle Invasive Bladder Cancer (NMIBC)
- What is being tested?
- HISA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Charleston Area Medical Center Memorial Hospital
Charleston, West Virginia, 25304
Jacqueline C Fannin, PhD, 6062250344, jacqueline.fannin@vandaliahealth.org
jacqueline.fannin@vandaliahealth.org
About this study
Official title: A Pilot Study Using Hyperthermic Irrigation Followed by Intravesical Chemotherapy in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer
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:
Read more
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
Read the detailed description
Non-muscle invasive bladder cancer (NMIBC) represents 75% of bladder cancer cases and recurs in up to 79% of patients. West Virginia carries disproportionately high bladder cancer incidence due to smoking, aging population, and occupational exposures. High recurrence requires frequent cystoscopy and intravesical therapy, creating a burden for rural Appalachian patients. New strategies to reduce recurrence and treatment are urgently needed.
Hyperthermic intravesical chemotherapy improves drug penetration and tumor cell sensitivity. However, the benefit of applying hyperthermic saline intraoperatively during resection of the bladder tumor is unknown. In this randomized, two-arm study, we will randomize 40 patients with low-risk appearing NMIBC to normothermic and hyperthermic saline irrigation during bladder tumor resection. Hyperthermic irrigation will be delivered at 42 ± 2° Celsius using the Stryker Thermaclear FluidSmart system. All patients will receive standard postoperative gemcitabine instillation. Follow-up visits will occur at 2 weeks, 3 and 6 months. The primary goal is feasibility, defined as 80% protocol adherence to hyperthermic irrigation. Secondary goals include safety, logistics, and patient retention. Additional outcomes include recurrence, adverse events, and patient-reported quality-of-life scores.
- Conditions
- Bladder Cancer, Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy), Non-muscle Invasive Bladder Cancer (NMIBC), Non-Muscle Invasive Bladder Neoplasms, Non-muscle Invasive Bladder Cancer, Bladder Cancer (BC)
- Being tested
- HISA
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HISADevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one year
Secondary outcomes (1)
Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates
To assess postoperative complications, adverse events, and readmission rates at 30- and 90-days. Adverse events will be monitored during the study for up to 90 days for each patient, assessed and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Aug 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia Clinical and Translational Science Institute
- Responsible party
- Principal investigator, Michael Stencel, CAMC Health System
- Investigators
- Michael G Stencel, DO, Principal investigator, CAMC Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817173
- Sponsor's protocol ID
- 25-1357
- Other IDs
- U54GM104942
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and confidentiality. The study includes sensitive health information, and even when data are de-identified, there is a small risk that participants could be identified. In addition, there are no current plans or resources to support data sharing agreements or external data requests. Summary results will be reported in publications instead.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Hyperthermic Irrigation Followed by Intravesical Chemotherapy in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07817173
- Acronym / sponsor ID
- 25-1357
- Conditions
- Bladder Cancer, Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy), Non-muscle Invasive Bladder Cancer (NMIBC), Non-Muscle Invasive Bladder Neoplasms, Non-muscle Invasive Bladder Cancer, Bladder Cancer (BC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Collaborators
- West Virginia Clinical and Translational Science Institute
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Non-muscle invasive bladder cancer (NMIBC) represents 75% of bladder cancer cases and recurs in up to 79% of patients. West Virginia carries disproportionately high bladder cancer incidence due to smoking, aging population, and occupational exposures. High recurrence requires frequent cystoscopy and intravesical therapy, creating a burden for rural Appalachian patients. New strategies to reduce recurrence and treatment are urgently needed.
Hyperthermic intravesical chemotherapy improves drug penetration and tumor cell sensitivity. However, the benefit of applying hyperthermic saline intraoperatively during resection of the bladder tumor is unknown. In this randomized, two-arm study, we will randomize 40 patients with low-risk appearing NMIBC to normothermic and hyperthermic saline irrigation during bladder tumor resection. Hyperthermic irrigation will be delivered at 42 ± 2° Celsius using the Stryker Thermaclear FluidSmart system. All patients will receive standard postoperative gemcitabine instillation. Follow-up visits will occur at 2 weeks, 3 and 6 months. The primary goal is feasibility, defined as 80% protocol adherence to hyperthermic irrigation. Secondary goals include safety, logistics, and patient retention. Additional outcomes include recurrence, adverse events, and patient-reported quality-of-life scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: HISAThe 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HISAThe 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. | Device | HISA |
Primary outcome
Patient Recruitment
Time frame: one year
The primary outcome will be patient recruitment. Patient recruitment will be the number of patients recruited divided by the total number of eligible patients.
Protocol Adherence for HISA Treatment
Time frame: one year
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.
1 secondary outcome
Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates
Time frame: Three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy and confidentiality. The study includes sensitive health information, and even when data are de-identified, there is a small risk that participants could be identified. In addition, there are no current plans or resources to support data sharing agreements or external data requests. Summary results will be reported in publications instead.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael G Stencel, DO principal investigator
CAMC Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HISA in people with Bladder Cancer and Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy), run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael G Stencel, DO (1-304-388-5280, michael.stencel@vandaliahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Recruitment (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.