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NCT Number: NCT07177924

Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS

This is a single-center, prospective, single-arm clinical study conducted at Beijing Cancer Hospital to evaluate the effectiveness, safety, and learning curve of preoperative indocyanine green (ICG) dye marking mixed with iodinated contrast agent under Monarch Robotic Assisted Bronchoscopy (RAB) with Cone-Beam CT (CBCT) for small pulmonary nodules that are difficult to locate during video-assisted thoracic surgery (VATS) sublobectomy. Eligible patients will undergo RAB localization immediately followed by VATS in the same operative session. The primary endpoints include the success rate of localization, effective localization, and VATS sublobar resection. Secondary endpoints include navigation success rate, operation times, reaching depth, complication rates, and health economic outcomes. The learning curve will be analyzed using the cumulative sum (CUSUM) method. A total of 50 patients will be enrolled and followed up for 14 days postoperatively.

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Key information

Conditions

Small Pulmonary Nodules Lung Cancer (Suspected or Confirmed) Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Pulmonary Nodule Localization Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Video-assisted Thoracoscopic Surgery (VATS)

Age range

18 year–80 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 18-80 years
  • Clinically indicated sub-lobar resection
  • Tolerates general anesthesia
  • Single/multiple small nodules <20 mm in peripheral lung field
  • Nodules difficult to locate intraoperatively by inspection/palpation

Exclusion criteria

  • Contraindications to bronchoscopy/anesthesia
  • Coagulopathy or bleeding tendency
  • Implanted devices interfering with navigation
  • Allergy to ICG or iodinated contrast
  • Pregnant/lactating women
  • Intraoperative findings not suitable for procedure

Treatment and study plan

Monarch RAB with CBCT-guided ICG Dye Marking

Procedure

Under general anesthesia, the Monarch RAB platform is used to navigate to the target bronchus. With CBCT confirmation, 0.25 ml of ICG (0.2 mg/ml) mixed with 0.25 ml iodinated contrast is injected within 1 cm of the nodule. The dye marking is identified intraoperatively with near-infrared light to guide VATS sublobectomy.

Primary outcomes

  1. Success rate of localization procedure

    Time frame: Periprocedural( localization procedure)

    Calculated as (number of successful localization procedures ÷ total localization procedures) × 100%. Success is defined as ICG dye successfully injected at planned target site as confirmed by CBCT. Unit of Measure: participants (%).

  2. Success rate of effective localization

    Time frame: Perioperative (during VATS)

    Calculated as [(number of successful localization procedures - number unrecognized in operative field) ÷ total localization procedures] × 100%. Effective localization is defined as visible ICG staining on pleura during VATS. Unit of Measure: participants (%).

  3. Success rate of VATS sub-lobar resection

    Time frame: Perioperative (during VATS)

    Calculated as (number of successful VATS resections ÷ total localization procedures) × 100%. Successful VATS resection is defined as resection containing the complete lesion and the dye together. Unit of Measure: participants (%).

Secondary outcomes

  1. Learning curve for localization

    Time frame: Through study completion, up to 8 months

    Number of cases required for surgeon to achieve proficiency using cumulative sum (CUSUM) method based on OT1 and localization success rate.Unit of Measure: case number.

  2. Bronchoscopy-related complication rate

    Time frame: From end of bronchoscopy through Postoperative Day 14.

    Incidence of pneumothorax, bleeding, and respiratory failure related to bronchoscopy, graded according to CTCAE. participants (%).

  3. Health economic outcomes

    Time frame: During index hospitalization

    Includes postoperative hospital stay, total hospitalization cost, complication treatment cost, anesthesia cost, and localization procedure cost. Unit of Measure: CNY.

Study contacts

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

Bingyang Huang

CONTACT

[email protected]

+8613161541915

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

Effectiveness, Safety and Learning Curve of Monarch Robotic Assisted Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS Sublobectomy

Acronym: REALM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2025
Registry last updated
Sep 17, 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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