Can heated saline during bladder surgery stop tumors from coming back?
NCT ID NCT07817173
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing whether heated saline can be safely given during surgery to remove early bladder tumors. The study enrolls adults with small papillary tumors that have not grown into the bladder muscle. Participants receive either heated saline or room-temperature saline during surgery, followed by gemcitabine chemotherapy placed directly into the bladder. The team tracks safety, side effects, and whether tumors return over the next six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- heated saline irrigation during bladder tumor surgery, followed by gemcitabine chemotherapy delivered into the bladder
- What this could lead to
- If it works, heating the bladder with saline during surgery could become a simple, low-cost way to lower the chance that early bladder tumors come back.
- What could go wrong
- This is a small pilot study of 40 people, so it can only hint at whether heated saline helps. The main goal is to check safety and whether the approach can be delivered as planned, not to prove it prevents recurrence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Charleston Area Medical Center Memorial Hospital
Charleston, West Virginia, 25304, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can tumor genes decide who keeps their bladder?
- Lab-Grown tumor models could match patients to the right cancer drug
- Radiation instead of bladder removal: a new option for Hard-to-Treat bladder cancer?
- Can an immunotherapy plus chemotherapy keep High-Risk bladder cancer at bay?
- Can a bladder rinse before surgery keep bladder cancer at bay?