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NCT Number: NCT06281080

First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours

This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.

Recruiting

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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

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Location status: Recruiting

Location contact

Chi Fai NG, MD

CONTACT

[email protected]

3505 2625

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
  • Body mass index <35 kg/m2
  • Bladder tumour located <3 cm in size; clinically non-muscle invasive bladder tumour
  • Clinically indicated for en-bloc resection.
  • Willingness to participate as demonstrated by giving informed consent

Exclusion criteria

  • Presence of endoscopic or imaging signs of detrusor muscle invasion
  • Contraindication to general anaesthesia / spinal anaesthesia
  • ASA > 2 patients
  • Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
  • Untreated active infection
  • Un-corrected coagulopathy
  • Presence of another malignancy or distant metastasis
  • Emergency surgery
  • Vulnerable population (e.g. mentally disabled, pregnant)

Treatment and study plan

En-Bloc Resection of Bladder Tumours

Procedure

Patients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.

Primary outcomes

  1. Successful en-bloc tumour resection by the robotic system

    Time frame: During the operation

    The number of cases completed the intervention by robotic system

Secondary outcomes

  1. Dissection time and speed

    Time frame: During operation

    Time required for submucosal dissection from the first cut

  2. Total procedure time

    Time frame: During operation

    Time from insertion of the robotic system into urethra until removal of the specimen from the body

  3. Surgeon Console time

    Time frame: During operation

    From the time start of any procedure to completion of urethral catheter insertion

  4. Presence of detrusor muscle in specimen

    Time frame: During operation

    Presence of detrusor muscle in specimen

  5. Resection Margin

    Time frame: During operation

    Number of subject with Negative resection margin

  6. Intra-operative bladder perforation event

    Time frame: During operation

    Number of subject

  7. Post-operative complications

    Time frame: Within 90 days after the study intervention

    Complication is defined according to the Clavien-Dindo Classification

  8. Need of bladder irrigation

    Time frame: Within 30 days after the study intervention.

    Number of subject

  9. Residual tumour or upstaging of tumour after second look TURBT

    Time frame: Within 30 days after the study intervention.

    Number of subject

Study contacts

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

Chi Fai NG, MD

CONTACT

[email protected]

35052625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Agilis Robotics Limited

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Feb 6, 2025

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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