Clinical trial · Interventional
Feasibility of HISA During TURBT for NMIBC
A Pilot Study Using Hyperthermic Irrigation Followed by Intravesical Chemotherapy in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Cancer (BC) | Malignant Bladder Neoplasm | CURATED_EXACT | 0.85 |
| Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy) | — | UNRESOLVED | — |
| Non-muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
| Non-muscle Invasive Bladder Cancer (NMIBC) | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.85 |
| Non-Muscle Invasive Bladder Carcinoma | Non-Muscle Invasive Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-Muscle Invasive Bladder Neoplasms | Non-Muscle Invasive Bladder Carcinoma | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HISA | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- No HISA
- description
- The control arm (no HISA) will consist of standard intraoperative care including bladder irrigation with normothermic saline during TURBT.
- type
- EXPERIMENTAL
- label
- HISA
- description
- 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.
- interventionNames
- Device: HISA
Primary outcomes (2)
- measure
- Patient Recruitment
- timeFrame
- one year
- description
- The primary outcome will be patient recruitment. Patient recruitment will be the number of patients recruited divided by the total number of eligible patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available