Lung NeoplasmNCT04529603
The Efficacy of Intraoperative Pulmonary Nodules Localization Guided by Virtual Reality Technology
A study testing LungBrella marker implantation and VATS partial lobe resection in people with Lung Neoplasm, run by Ruijin Hospital at 1 site in China.
Trial summary
As the detection of small pulmonary nodules continuously grows, the intraoperative localization of small pulmonary nodules is in great demand. The intraoperative localization nowadays is usually done under local anesthesia before surgery. There is a certain rate of failure and complication. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Neoplasm
- What is being tested?
- LungBrella marker implantation and VATS partial lobe resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Oct 2022
- 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
- diagnosis of pulmonary nodule, single nodule operation to be performed and nodule to be located by the decision of chief surgeon. • commit to follow the research procedures and cooperate with the implementation of the whole process research • 1 / 3 of pulmonary nodules are located in the periphery of the lung • signed informed consent with date
Who cannot join
- the target lesion is close to the hilar or large blood vessels • subjects with FEV1 less than 1.2 in lung function • subjects with cardiac function III and cardiac function IV (NYHA, New York) • subjects with uncontrollable acute pleura infection • patients with previous history of thoracic surgery (thoracotomy), plural infection, and plural thickening and adhesion on the affected side • Other factors that investigators disagree enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Localizing of Intraoperative Pulmonary Nodules Guided by Virtual Reality Technology
As the detection of small pulmonary nodules continuously grows, the intraoperative localization of small pulmonary nodules is in great demand. The intraoperative localization nowadays is usually done under local anesthesia before surgery. There is a certain rate of failure and complication. The result of our early animal experiments show that the pulmonary surgery marker system can deliver the intraoperative localization safely and precisely under anesthesia, and the average distance between the localization and the simulated lesion is less than 5mm during surgery. Therefore, the safety and feasibility of the system require further evaluation in patients
Read the detailed description
This is a prospective, mulitiple-center clinical trial initiated by the investigator. LungBrella marker can be accurately implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery. The study is expected to enroll 90 patients. Finally, the effectiveness and safety of the method will be evaluated. This method not only can complete pulmonary nodule localization in the operating room without occupying the resources of radiology department, but also can let patients receive pulmonary nodule location after anesthesia. Thereby the risks during transportation are avoided and the suffering of patients is reduced.
- Conditions
- Lung Neoplasm
- Being tested
- LungBrella marker implantation and VATS partial lobe resection
- Keywords
- Lung Neoplasm, localization of lung nodules, ground glass opacity, sublobar resection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LungBrella marker implantation and VATS partial lobe resectionDevice
The enrolled patients will receive a plain chest CT scan,then the data be loaded into JediVision software. The JediVision software can navigate the location of nodule and facilitate the implantation of LungBrella marker in the operating room after general anesthesia,then the patients will receive VATS partial lobe resection .
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | LungBrella marker implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery Receives: Device: LungBrella marker implantation and VATS partial lobe resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positioning success rate
When the distance between the LungBrella marker and the Pulmonary nodule is less than 10mm, the marker position is successful. The success rate is the proportion of successful cases to all operation cases
Measured: Immediately after resection
Secondary outcomes (1)
Procedure time
Collect total procedure time for lung localization and surgical resection.
Measured: Duration of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Why it stopped: The previous studies did not show convincing results of this technology.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Futuo Zhida Medical Technology Co., Ltd
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
- Investigators
- Hecheng Li, Principal investigator, Ruijin hospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529603
- Sponsor's protocol ID
- RTS-012
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Localizing of Intraoperative Pulmonary Nodules Guided by Virtual Reality Technology
- ClinicalTrials.gov ID
- NCT04529603
- Acronym / sponsor ID
- RTS-012
- Conditions
- Lung Neoplasm
- Keywords
- Lung Neoplasm, localization of lung nodules, ground glass opacity, sublobar resection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The previous studies did not show convincing results of this technology.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Futuo Zhida Medical Technology Co., Ltd
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 27 Aug 2020 (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.
As the detection of small pulmonary nodules continuously grows, the intraoperative localization of small pulmonary nodules is in great demand. The intraoperative localization nowadays is usually done under local anesthesia before surgery. There is a certain rate of failure and complication. The result of our early animal experiments show that the pulmonary surgery marker system can deliver the intraoperative localization safely and precisely under anesthesia, and the average distance between the localization and the simulated lesion is less than 5mm during surgery. Therefore, the safety and feasibility of the system require further evaluation in patients
Detailed description
This is a prospective, mulitiple-center clinical trial initiated by the investigator. LungBrella marker can be accurately implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery. The study is expected to enroll 90 patients. Finally, the effectiveness and safety of the method will be evaluated. This method not only can complete pulmonary nodule localization in the operating room without occupying the resources of radiology department, but also can let patients receive pulmonary nodule location after anesthesia. Thereby the risks during transportation are avoided and the suffering of patients is reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: LungBrella marker implantation and VATS partial lobe resectionLungBrella marker implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of pulmonary nodule, single nodule operation to be performed and nodule to be located by the decision of chief surgeon. • commit to follow the research procedures and cooperate with the implementation of the whole process research • 1 / 3 of pulmonary nodules are located in the periphery of the lung • signed informed consent with date
Key exclusion criteria (1 listed)
- the target lesion is close to the hilar or large blood vessels • subjects with FEV1 less than 1.2 in lung function • subjects with cardiac function III and cardiac function IV (NYHA, New York) • subjects with uncontrollable acute pleura infection • patients with previous history of thoracic surgery (thoracotomy), plural infection, and plural thickening and adhesion on the affected side • Other factors that investigators disagree enrollment.
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 |
|---|---|---|
| LungBrella marker implantation and VATS partial lobe resectionThe enrolled patients will receive a plain chest CT scan,then the data be loaded into JediVision software. The JediVision software can navigate the location of nodule and facilitate the implantation of LungBrella marker in the operating room after general anesthesia,then the patients will receive VATS partial lobe resection . | Device | Arm 1 |
Primary outcome
Positioning success rate
Time frame: Immediately after resection
When the distance between the LungBrella marker and the Pulmonary nodule is less than 10mm, the marker position is successful. The success rate is the proportion of successful cases to all operation cases
1 secondary outcome
Procedure time
Time frame: Duration of procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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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.
Hecheng Li principal investigator
Ruijin hospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LungBrella marker implantation and VATS partial lobe resection in people with Lung Neoplasm, run by Ruijin Hospital 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Sep 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Positioning success rate (time frame: Immediately after resection). 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 2 Sep 2021.