Thoracic Surgery by the Medtronic Hugo™ Robotic System

NCT06669104 | Recruiting FDA Device

• 1 other identifier: CUHK HUGO
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Cancer

Keywords

robotic assisted thoracic surgery; minimally invasive surgery; lung cancer; mediastinal tumour

Outcome Measures

Primary Outcomes (2)

• The conversion rate

  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

  1 year

• The peri-operative complication

  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.

  1 year

Secondary Outcomes (5)

• Completeness of Resection evaluated by histopathological analysis

  1 month

• Resection margin measured by histopathological methods

  1 month

• Number of Lymph Nodes Harvested assessed through pathological examination

  1 month

• Clinical Recurrence investigated through follow-up imaging

  1 year

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

  1 year

Study Arms (3)

Lobectomy , Segmentectomy Wedge resection of lung

Device: Medtronic Hugo™ surgical robotic system

Anterior Mediastinal Tumour Resection

Device: Medtronic Hugo™ surgical robotic system

Posterior Mediastinal Tumour Resection

Device: Medtronic Hugo™ surgical robotic system

Interventions

Medtronic Hugo™ surgical robotic system DEVICE

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

Anterior Mediastinal Tumour Resection; Lobectomy , Segmentectomy Wedge resection of lung; Posterior Mediastinal Tumour Resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are advised to have robotic thoracic procedures

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

lung specimen

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Calvin Sze Hang Ng

  CUHK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calvin Sze Hang Ng

CONTACT

85235052629; calvinng@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: November 1, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

HK (1)