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NCT Number: NCT06669104

Thoracic Surgery by the Medtronic Hugo™ Robotic System

The introduction of robot-assisted surgery is one of the biggest breakthroughs in surgery, and represents the most significant advancement in minimally invasive surgery of recent decades. One of the first surgical uses of the robot was in orthopaedics, neurosurgery and cardiac surgery. However, it's use has now been well recognized in thoracic surgical procedures ranging from mediastinal tumour resection to complex major lung resections.

Robotic surgery by the da Vinci Surgical System (Intuitive Surgical, Inc) has been one of the most commonly used robotic systems in surgery. The robotic system overcomes the limitations of the standard thoracoscopic approach and allows for precise dissection in a confined space. These advantages include stable operator-controlled camera, high- definition 3D magnified view of 10 to 12 times, articulating instruments with seven degrees of freedom, motion scaling, and tremor filtration.

Recently the Medtronic Hugo™ surgical robotic system has passed the CE mark. This robotic platform, made up of modular surgical arms on wheeled carts, has started its operation in human in Latin America, Europe and the Asia-Pacific region. The Hugo™ system is designed to provide a lower barrier to entry for hospitals looking to expand their reach in robotic surgery. Compared to the platform by Intuitive Surgical, Hugo™can be customized with up to four independent arms, and rolled to different locations in a hospital when needed.

The investigator's centre is the first robotic surgical centre in Hong Kong since 2005. Over the years, the investigator have established the centre to be one of the leading centre in Hong Kong and the region, with involvement in various new development in thoracic robotic procedures, publications and books, and more recently in robotic endo-lumenal procedures.

In this study, the investigator evaluate the early surgical outcome and objective functional outcome of patients undergoing robotic thoracic surgery by the Medtronic Hugo™ surgical robotic system.

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Key information

Conditions

Thoracic Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong

Location status: Recruiting

Location contact

Calvin Sze Hang Ng

CONTACT

[email protected]

35052629

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 - 80 years
  • Body mass index <35 kg/m2
  • Suitable for minimally invasive surgery
  • Willingness to participate as demonstrated by giving informed consent

Exclusion criteria

  • Contraindication to general anaesthesia
  • Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
  • Untreated active infection
  • Non-correctable coagulopathy
  • Emergency surgery
  • Vulnerable population (e.g. mentally disabled, pregnancy)

Treatment and study plan

Medtronic Hugo™ surgical robotic system

Device

undergoing robotic thoracic surgery by the Medtronic Hugo™ surgical robotic system

Primary outcomes

  1. The conversion rate

    Time frame: 1 year

    The feasibility of the Medtronic Hugo™ robotic system for thoracic robotic procedures (anterior mediastinal tumour resection, posterior mediastinal tumour resection and lung resection (wedge, segmentectomy, lobectomy), as measured by the conversion rate

  2. The peri-operative complication

    Time frame: 1 year

    The safety profile of the Medtronic Hugo™ robotic system for thoracic robotic procedures (anterior mediastinal tumour resection, posterior mediastinal tumour resection and lung resection (wedge, segmentectomy, lobectomy), as measured by the peri-operative complication profile.

Secondary outcomes

  1. Completeness of Resection evaluated by histopathological analysis

    Time frame: 1 month

    Evaluated by assessing whether the surgical margins are free of tumor as determined by histopathological analysis.

    If the tumor is not touching the resection margins, it is considered a complete resection; If tumor cells are present at the margins, this indicates an incomplete resection.

  2. Resection margin measured by histopathological methods

    Time frame: 1 month

    Measured in millimeters by histopathological methods, indicating the distance from the tumor to the closest margin.

  3. Number of Lymph Nodes Harvested assessed through pathological examination

    Time frame: 1 month

    Total count of lymph nodes excised during the procedure, assessed through pathological examination.

  4. Clinical Recurrence investigated through follow-up imaging

    Time frame: 1 year

    Clinical Recurrence: Monitored through follow-up imaging and clinical evaluations at specified time intervals to determine any recurrence of the disease

    Local recurrence rate (for cancer surgery) will be calculated using the Kaplan-Meier method, and differences between groups will be compared using the log-rank test. A 2-sided P value <0.05 is considered to be statistically significant.

  5. Functional outcome (pre and post lung function test) will be collected

    Time frame: 1 year

    The functional outcomes for lung resection procedures (wedge, segmentectomy, lobectomy) will be assessed by conducting lung function tests. The following parameters will be measured:

    Pulmonary Function Tests (PFTs):

    Forced Vital Capacity (FVC): Measures the maximum amount of air a person can forcibly exhale after taking a deep breath, the measure unit is Liter.

    Forced Expiratory Volume in 1 second (FEV1): Measures the amount of air a person can forcibly exhale in one second, the measure unit is Liter.

    Diffusion Capacity for Carbon Monoxide (DLCO): Assesses how well oxygen and carbon dioxide are exchanged in the lungs, the measure unit is ml/min/mm Hg.

Study contacts

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

Calvin Sze Hang Ng

CONTACT

[email protected]

85235052629

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Thoracic Surgery by the Medtronic Hugo™ Robotic System: A Prospective Single Centre Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 1, 2024
Registry last updated
Mar 20, 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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