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NCT Number: NCT07201077

ArticuGrasp Trial: New Flexible Tool vs Standard Grasper for Lung Cancer Node Removal in Keyhole Chest Surgery

This study is testing whether a new, flexible surgical tool-the SurgeoFlex Grasp-makes keyhole chest operations for early-stage lung cancer easier, faster, and safer than the standard rigid tool used today.

What is the problem? In keyhole (uniportal) chest surgery, formally known as single-port video-assisted thoracoscopic surgery (VATS), surgeons reach the lung through one small incision between the ribs. Because the operating space is tight, the usual stiff instruments can bump into each other and into surrounding tissues. This difficulty can prolong lymph-node removal and increase the risk of complications.

What is being tested?

The trial compares two handheld tools:

SurgeoFlex Grasp (intervention): a slim, bendable grasper that can be steered around corners.

Traditional EndoGrasper (control): a straight, rigid grasper currently used as the standard.

Who is taking part? Approximately 100 adults with early-stage non-small-cell lung cancer (NSCLC) (tumours 3 cm or smaller) who are scheduled for keyhole surgery at The First Affiliated Hospital of Guangzhou Medical University.

What will happen?

Participants are allocated by randomisation into one of two groups:

SurgeoFlex group-surgeons use the new flexible tool. Control group-surgeons use the standard rigid tool. All other aspects of the operation, anaesthesia, and post-operative care remain identical for both groups.

What is measured? Lymphadenectomy time (duration required to remove the specified lymph nodes). Number of lymph nodes successfully removed. Frequency of surgical-instrument collisions or interference (instrument-clash events).

Surgeon workload during the operation (assessed with the National Aeronautics and Space Administration Task Load Index [NASA-TLX]).

Skin-incision length, pain scores (Visual Analogue Scale [VAS]), recovery time, infection rates, and overall cost.

Quality-of-life scores one month after surgery (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] and its lung-cancer module [EORTC QLQ-LC13]).

What is expected? The investigators expect the SurgeoFlex Grasp to shorten operative time, reduce instrument interference, lower surgeon stress, and accelerate recovery without increasing cost.

How will this help patients? If the new tool performs as anticipated, future patients undergoing keyhole lung-cancer surgery may experience shorter operations, smaller scars, less pain, and lower infection risk while still obtaining complete cancer-related lymph-node removal.

Where is the study taking place? The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.

Contact for more information:

Clinical Research Management Committee 151 Yanjiang Road, Yuexiu District, Guangzhou 510120, China Email: [email protected]

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

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

Eligibility Criteria

Inclusion criteria

  • Age 18-70 years, any sex
  • BMI 18.5-30 kg/m²
  • Newly diagnosed non-small-cell lung cancer with pre-operative clinical stage cT1-2N0-1M0
  • Scheduled to undergo single-port video-assisted thoracoscopic lobectomy with systematic lymph-node dissection
  • Major organ function sufficient for surgery
  • Written informed consent provided

Exclusion criteria

  • Small-cell lung cancer or mixed-type lung cancer
  • Tumor invasion of main bronchus, chest wall, diaphragm, or major mediastinal vessels
  • Previous ipsilateral thoracic surgery or prior neoadjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy
  • Severe cardiopulmonary dysfunction (FEV₁ <50 % predicted or LVEF <40 %)
  • Pregnant or breastfeeding women
  • Participation in another interventional clinical trial

Treatment and study plan

Articulating lymph-node grasper (SurgeoFlex Grasp)

Device

Arm 1 - SurgeoFlex Grasp A single-use, low-profile articulating grasper with a 5-millimetre (mm) shaft and a 360-degree (360°) steerable distal tip. During uniportal video-assisted thoracoscopic surgery (UVATS), the device is introduced through the same 3-4-centimetre (cm) utility incision used for the camera and stapler. The flexible neck allows the jaws to approach hilar and mediastinal lymph nodes from multiple angles without repositioning the instrument shaft, thereby reducing instrument collision and chest-wall torque.

Arm 2 Intervention Name Traditional rigid endograsper

Device

Arm 2 - Traditional Rigid EndoGrasper A reusable, straight-shafted 5 mm grasper with fixed-angle jaws identical to those used in conventional multi-port video-assisted thoracoscopic surgery (VATS). The instrument is passed through the single 3-4 cm incision in the same fashion as the SurgeoFlex Grasp, but its rigid shaft limits the working angle and often requires external repositioning of the entire instrument to reach deep lymph-node stations.

Primary outcomes

  1. Duration of Systemic Lymph Node Dissection (SLND)

    Time frame: Intraoperative; measured from the start of the first lymph node packet dissection to the completion of the final packet removal, up to a maximum of 60 minutes.

Secondary outcomes

  1. Number of Lymph Nodes Retrieved

    Time frame: Intraoperatively, assessed immediately after the completion of systemic lymph node dissection.

  2. Instrument Collision Counts

    Time frame: Intraoperatively, continuously recorded during systemic lymph node dissection and averaged per case.

  3. Surgeon Cognitive Load (NASA-TLX score)

    Time frame: Intra-operatively, within 10 minutes after skin closure.

    National Aeronautics and Space Administration Task Load Index (NASA-TLX). The NASA-TLX is a multidimensional assessment tool that rates perceived workload across six subscales to assess a task's mental, physical, and temporal demands, as well as the performer's effort, frustration, and performance. The subscale ratings are combined into a weighted composite score. Range: 0-100 points (weighted composite of 6 subscales). Interpretation: Higher scores indicate greater perceived workload.

  4. Skin Incision Length

    Time frame: At the end of the operation, before skin closure.

  5. Post-operative Pain Score (0-10 numeric rating scale)

    Time frame: Daily during the first 3 post-operative days.

  6. Incidence of Post-operative Infections

    Time frame: Within 30 days after surgery.

  7. Operating Room Occupancy Time

    Time frame: Time Frame: Intra-operatively, from skin incision to wound closure, up to 6 hours.

  8. Health-related Quality of Life (SF-36 score)

    Time frame: Assessed 1 month after surgery.

    36-Item Short-Form Health Survey (SF-36) quality-of-life score. The SF-36 is a standardized, self-administered survey evaluating eight health domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Range: 0-100 points (each of the 8 domains is scored 0-100). Interpretation: A higher score indicates a better health status and quality of life.

  9. Incidence of Device Malfunction

    Time frame: From device insertion to device removal, assessed continuously during each operation.

Sponsors and collaborators

Lead sponsor

Jianxing He

Other

Registry information

Official study title

Overcoming Instrumentation Challenges in Real-World Uniportal Video-Assisted Thoracoscopic Surgery: A Prospective, Randomized, Controlled Trial Evaluating the SurgeoFlex Grasp Versus the Traditional Endograsper for Systemic Lymph Node Dissection in Patients With Early-Stage Non-Small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2025
Registry last updated
Oct 1, 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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