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NCT Number: NCT07727343

AI-Guided TURBT for Bladder Cancer

This prospective, randomized, controlled, single-center study evaluates whether an AI navigation planning system used during Transurethral Resection of Bladder Tumor (TURBT) can improve recurrence-free survival in patients with non-muscle invasive bladder cancer. Participants are randomized to receive either standard TURBT surgery or standard TURBT with AI-assisted real-time tumor identification and resection margin guidance. The primary outcome is recurrence-free survival, with secondary outcomes including surgical duration, intraoperative blood loss, perioperative bleeding, and complication rates. The study aims to provide high-level evidence on the clinical utility of AI-assisted surgical navigation in bladder cancer treatment.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 75 years, male or female.
  • Clinical or imaging diagnosis of non-muscle invasive bladder cancer (NMIBC) according to international diagnostic standards (CT, MRI, ultrasound, cystoscopy).
  • Medically fit for TURBT surgery, with normal or essentially normal renal, cardiopulmonary, and hepatic function.
  • Willing and able to provide written informed consent (signed by the patient or a legally authorized representative).

Exclusion criteria

  • Pregnant or lactating women.
  • Severe dysfunction of other vital organs (heart, lungs, kidneys, etc.).
  • Imaging evidence of distant metastases.
  • Severe infection or active inflammation.
  • Psychiatric disorders or inability to comply with study procedures.
  • Any other condition deemed by the investigator as inappropriate for participation.

Treatment and study plan

AI Navigation Planning System

Device

The AI Navigation Planning System is a software-based medical device that processes real-time video from a standard cystoscope during TURBT. It uses deep learning algorithms to automatically identify suspicious tumor regions and perform semantic segmentation of tumor boundaries on the endoscopic video stream. The system overlays the identified tumor areas and dynamically recommended resection margins onto the surgical monitor as visual guidance for the surgeon. The system achieves a diagnostic accuracy of 97% and an AUC of 0.97 in multi-center validation. It is designed to assist surgeons in achieving more complete tumor resection by reducing reliance on subjective visual assessment alone. The system operates locally on a standard workstation without requiring internet connectivity, ensuring data security.

Primary outcomes

  1. Recurrence-Free Survival (RFS)

    Time frame: Time Frame: Up to 24 months post-surgery

    Time from surgery to the first occurrence of tumor recurrence confirmed by imaging (CT/MRI/ultrasound) or cystoscopy with pathological biopsy, or death from any cause, whichever occurs first. Participants without an event at the end of follow-up will be censored at the date of the last known follow-up visit.

Secondary outcomes

  1. Surgical Duration

    Time frame: Day of surgery (intraoperative)

    Time from cystoscope entry into the bladder to successful placement of the urinary catheter at the end of surgery, recorded in minutes.

  2. Intraoperative Blood Loss

    Time frame: Day of surgery (intraoperative

    Total blood loss during surgery, calculated by suction canister fluid minus irrigation fluid plus gauze weighing method, recorded in milliliters (mL).

  3. Perioperative Bleeding Rate

    Time frame: Up to 14 days post-surgery

    Proportion of participants experiencing bleeding requiring interventional therapy, unplanned reoperation, or blood transfusion within 14 days post-surgery.

  4. Number of Lesions Detected Intraoperatively

    Time frame: Day of surgery (intraoperative)

    Total number of tumor lesions identified and documented during the surgical procedure.

  5. Postoperative Residual Lesion Rate

    Time frame: Up to 3 months post-surgery

    Proportion of participants with residual or newly detected lesions at the first postoperative cystoscopy follow-up visit.

  6. Surgery-Related Complication Rate

    Time frame: Up to 30 days post-surgery

    Incidence and severity of postoperative complications graded according to the Clavien-Dindo Classification (Grade I to V) within 30 days post-surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajun Wang, MD

CONTACT

[email protected]

+86-15201926887

Lingzhi Du, MD

CONTACT

[email protected]

+86-19839759960

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Evaluation of the Efficacy and Safety of an AI Navigation Planning System in Transurethral Resection of Bladder Tumor: A Prospective, Randomized, Controlled, Single-Center Study

Acronym: AITURBT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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