Non-Small Cell Lung CancerNCT07201077
ArticuGrasp Trial: New Flexible Tool vs Standard Grasper for Lung Cancer Node Removal in Keyhole Chest Surgery
A study testing Articulating lymph-node grasper (SurgeoFlex Grasp) and Arm 2 Intervention Name Traditional rigid endograsper in people with Non-Small Cell Lung Cancer, run by Jianxing He at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Articulating lymph-node grasper (SurgeoFlex Grasp) and Arm 2 Intervention Name Traditional rigid endograsper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official 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
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.
Read more
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: crmc@gzhmu.edu.cn
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Articulating lymph-node grasper (SurgeoFlex Grasp), Arm 2 Intervention Name Traditional rigid endograsper
- Keywords
- SurgeoFlex grasp, Systematic lymph node dissection, Uniportal video-assisted thoracoscopic surgery, Minimally invasive thoracic surgery, Lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 endograsperDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SurgeoFlex Grasp (SFG) | Experimental | Participants receive UVATS with SurgeoFlex Grasp for lymph-node dissection. Receives: Device: Articulating lymph-node grasper (SurgeoFlex Grasp) |
| Traditional Endograsper (TER) | Active comparator | Participants receive UVATS with Traditional Endograsper for lymph-node dissection. Receives: Device: Arm 2 Intervention Name Traditional rigid endograsper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Systemic Lymph Node Dissection (SLND)
Measured: 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 (9)
Number of Lymph Nodes Retrieved
Measured: Intraoperatively, assessed immediately after the completion of systemic lymph node dissection.
Instrument Collision Counts
Measured: Intraoperatively, continuously recorded during systemic lymph node dissection and averaged per case.
Surgeon Cognitive Load (NASA-TLX score)
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.
Measured: Intra-operatively, within 10 minutes after skin closure.
Skin Incision Length
Measured: At the end of the operation, before skin closure.
Post-operative Pain Score (0-10 numeric rating scale)
Measured: Daily during the first 3 post-operative days.
Incidence of Post-operative Infections
Measured: Within 30 days after surgery.
Operating Room Occupancy Time
Measured: Time Frame: Intra-operatively, from skin incision to wound closure, up to 6 hours.
Health-related Quality of Life (SF-36 score)
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.
Measured: Assessed 1 month after surgery.
Incidence of Device Malfunction
Measured: From device insertion to device removal, assessed continuously during each operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Jan 2025
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianxing He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201077
- Sponsor's protocol ID
- ES-2025-165-01
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07201077
- Acronym / sponsor ID
- ES-2025-165-01
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- SurgeoFlex grasp, Systematic lymph node dissection, Uniportal video-assisted thoracoscopic surgery, Minimally invasive thoracic surgery, Lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jianxing HeUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: crmc@gzhmu.edu.cn
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SurgeoFlex Grasp (SFG) | Experimental | Device: Articulating lymph-node grasper (SurgeoFlex Grasp)Participants receive UVATS with SurgeoFlex Grasp for lymph-node dissection. |
| Traditional Endograsper (TER) | Active comparator | Device: Arm 2 Intervention Name Traditional rigid endograsperParticipants receive UVATS with Traditional Endograsper for lymph-node dissection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Articulating lymph-node grasper (SurgeoFlex Grasp)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. | Device | SurgeoFlex Grasp (SFG) |
| Arm 2 Intervention Name Traditional rigid endograsperArm 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. | Device | Traditional Endograsper (TER) |
Primary outcome
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.
9 secondary outcomes
Number of Lymph Nodes Retrieved
Time frame: Intraoperatively, assessed immediately after the completion of systemic lymph node dissection.
Instrument Collision Counts
Time frame: Intraoperatively, continuously recorded during systemic lymph node dissection and averaged per case.
Surgeon Cognitive Load (NASA-TLX score)
Time frame: Intra-operatively, within 10 minutes after skin closure.
Skin Incision Length
Time frame: At the end of the operation, before skin closure.
Post-operative Pain Score (0-10 numeric rating scale)
Time frame: Daily during the first 3 post-operative days.
Incidence of Post-operative Infections
Time frame: Within 30 days after surgery.
Operating Room Occupancy Time
Time frame: Time Frame: Intra-operatively, from skin incision to wound closure, up to 6 hours.
Health-related Quality of Life (SF-36 score)
Time frame: Assessed 1 month after surgery.
Incidence of Device Malfunction
Time frame: From device insertion to device removal, assessed continuously during each operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Articulating lymph-node grasper (SurgeoFlex Grasp) and Arm 2 Intervention Name Traditional rigid endograsper in people with Non-Small Cell Lung Cancer, run by Jianxing He at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.