RecruitingNot ApplicableNCT06679920

Study With a Newly Optical Coherence Tomography Probe for Optimizing Bladder Cancer Diagnosis and Treatment

IDEAL Phase II Study of a Newly Designed Optical Coherence Tomography Probe During Transurethral Resection for Optimizing Bladder Cancer Diagnosis and Treatment


Sponsor

Amsterdam UMC

Enrollment

15 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to see if a new designed optical coherence tomography catheter can be used in bladder cancer in patients undergoing a transurethral resection of a bladder tumour. The main question it aims to answer is: \- Is the optical coherence tomography catheter feasible in capturing images of bladder tumours and normal bladder wall during a transurethral resection of a bladder tumour? Participants will undergo measurements with a new optical coherence tomography device during the transurethral resection of their bladder tumour(s).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Age \> 18 years.
  • Have at least 1 suspected bladder tumour seen at cystoscopy.
  • Have a bladder that is accessible for cystoscopy.
  • Be in a physical condition to undergo a TURBT.
  • Eligible patients must be fully informed about the study and written signed informed consent must be obtained prior to any study related investigation/intervention.

Exclusion Criteria5

  • Pregnant or lactating women.
  • The only tumour site is at the bladder neck.
  • The tumour(s) is larger than 2 centimetres in diameter.
  • \>5 tumours present.
  • Solely a suspected flat lesion present.

Interventions

DEVICEOptical coherence tomography

Measurement with opctical coherence tomography of tumour and normal bladder tissue during transurethral resection of a bladder tumour (TURBT)


Locations(2)

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands

Amsterdam University Medical Center

Amsterdam, Netherlands

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NCT06679920


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