Can a Bag-Like device pull bladder tumors out whole?
NCT ID NCT07762820
First seen Aug 13, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This trial tests a new tool called CURTIS, designed to safely remove bladder tumors in one intact piece after they are cut out during surgery. The goal is to see how often the device can successfully retrieve the tumor without breaking it apart, and what the largest tumor size is that it can handle. The study involves 75 adults with suspected early-stage bladder cancer who are scheduled for standard tumor removal surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CURTIS retrieval device, a bag-like tool to capture and remove the resected bladder tumor intact through the urethra
- What this could lead to
- If successful, this device could make en-bloc removal of bladder tumors easier and more reliable, potentially reducing the need for repeat procedures and improving diagnosis.
- What could go wrong
- This is an early feasibility study with a small number of patients. The device may not work for larger tumors, and there is a risk of tumor fragmentation or damage during retrieval.
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 75 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
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 years and older
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years at the time of enrollment * Suspected primary non-muscle invasive bladder cancer (NMIBC; stage pTa or pT1) based on cystoscopic assessment, with no radiological or clinical evidence of muscle-invasive disease * Solitary or multiple bladder tumors with an estimated largest diameter of ≤50 mm based on flexible or rigid cystoscopic assessment (or cross-sectional imaging if available) * Clinical indication for elective transurethral resection of the bladder tumor, planned to be performed as en-bloc resection * Written informed consent obtained prior to any study-related procedure * Ability to understand the study procedures and willingness to comply with study requirements Exclusion Criteria: * Known or clinically suspected muscle-invasive bladder cancer (MIBC; cT2 or higher) based on cystoscopy or imaging * Recurrent bladder tumor (prior history of bladder tumor resection within the past 24 months) * Active untreated urinary tract infection at the time of surgery (requiring postponement and re-evaluation) * Uncorrectable coagulopathy or anticoagulation that cannot be safely paused perioperatively * Severe urethral stricture precluding standard resectoscope passage * Inability to provide written informed consent (e.g., due to cognitive impairment or language barrier without translation support)
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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
9 sites in 3 countries. 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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Department of Surgery, Queen Ingrid's Hospital
Nuuk, 3900, Greenland
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Department of Urology, Aarhus University Hospital, Aarhus
Aarhus, 8200, Denmark
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Klinik für Urologie, Klinikum Nürnberg, Campus Nord
Nuremberg, Bavaria, 90419, Germany
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Universtitätsklinikum Erlangen
Erlangen, Bavaria, 91504, Germany
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Urologie, Barmherzige Brüder Krankenhaus München
Munich, Bavaria, 80639, Germany
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Urologie, Universitätsklinikum Augsburg
Augsburg, Bavaria, 86156, Germany
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Urologische Klinik und Poliklinik, LMU Klinikum
Munich, Bavaria, 81377, Germany
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Urologische Klinik, Klinikum Rechts der Isar
Munich, Bavaria, 81675, Germany
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Zealand University Hospital, Roskilde
Roskilde, 4000, Denmark
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
- Can heated saline during bladder surgery stop tumors from coming back?
- 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?