Lung CancerNCT04139408
Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
A study testing Disposable Pulmonary Surgical Marker in people with Lung Cancer, run by Hangzhou Broncus Medical Co., Ltd. at 3 sites in China.
Trial summary
During the VATS procedure, some pulmonary nodules are relatively small or far away from the pleura, resulting that they are difficult to be accurately located during the procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Disposable Pulmonary Surgical Marker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesChina
- Study dates
- 22 Jul 2020to 26 Jan 2021
- 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 old；
- Pulmonary nodule, which satisfying any of the following Criteria:
- solid nodules with diameter ≤1 cm or solid component ≤1 cm non-purely ground glass, and the distance between the solid component of the nodule and the visceral pleural>0.5cm;
- Pure ground glass opacity (pGGO)；
- Before VATS operation, the doctor judge that the nodule is difficult to locate during the operation.
- Pulmonary wedge resection or Segmental pulmonary resection under VATS is proposed;
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- Preoperative evaluation shows that placing marker through bronchus is feasible；
- The subject is able to fully understand the requirements of clinical research;
- Subject or the legal representative signs the informed consent form.
Who cannot join
- Contraindications for bronchoscopy;
- Systemic factors: sepsis, history of repeated pulmonary infections, and any type of severe infectious disease within one month of screening；
- Severe cardio and pulmonary disease；
- Coagulation dysfunction, with a clear tendency to bleed;
- General anesthesia contraindication;
- Allergic history of nickel-titanium materials;
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- Breast-feeding or may be or plan to be pregnant during the trial;
- Participating in clinical trials of other drugs or medical devices;
- Other conditions that Investigator consider the subject to be inappropriate.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Yunnan Cancer Hospital
Kunming
Cancer Hospital of Chinese Academy of Medical Sciences,Shenzhen Center
Shenzhen
About this study
Official title: A Prospective, Multicenter, Single Group Clinical Study to Evaluate the Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
During the VATS procedure, some pulmonary nodules are relatively small or far away from the pleura, resulting that they are difficult to be accurately located during the procedure.
The aim of this study is to evaluate the efficacy and safety of using disposable pulmonary surgical markers to localize pulmonary nodules in subjects prior to the resection of pulmonary nodules by video-assisted thoracoscopic surgery (VATS).
Read the detailed description
It is a prospective, multicenter, single group target value clinical trial. The subjects will undergo VATS within 24h after the placement of the Marker, then the Marker and targeted nodule will be removed during VATS. Subjects will be followed up intraoperatively, immediately after placement procedure to the end of VATS resection, 7 days after placement procedure/before discharge (whichever occurs earlier), and 30 days after Marker placement procedure. Demographic and baseline information of subjects, immediate operation success rate of marker placement, positioning success rate, and adverse events will be collected and recorded in this study.
- Conditions
- Lung Cancer
- Being tested
- Disposable Pulmonary Surgical Marker
- Keywords
- Pulmonary Nodule, Localization, Marker
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable Pulmonary Surgical MarkerDevice
The subjects will undergo Marker placement procedure, within 24h before VATS.
| Study group | Role | What they receive |
|---|---|---|
| Disposable Pulmonary Surgical Marker | Experimental | Locate the pulmonary nodules with Disposable Pulmonary Surgical Marker before VATS. Receives: Device: Disposable Pulmonary Surgical Marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positioning success rate
The proportion of patients who complete VATS resection of target pulmonary nodules/number of patients receiving localization of target pulmonary nodules before operation, expressed as "rate", will be evaluated during and immediately after surgery to evaluate the effectiveness of disposable pulmonary surgical markers in the localization of pulmonary nodules in surgery.
Measured: Immediately after VATS
Secondary outcomes (6)
Positioning success rate (in terms of marker placement)
The proportion of target pulmonary nodules underwent VATS resection/number of pulmonary nodules receiving localization before operation, expressed as "rate".
Measured: Immediately after VATS
Immediate operation success rate of marker placement (in terms of marker, placement),including the following operations:
- The marker conveyor goes through the bronchoscope and reaches the target release position
- Marker is successfully released
- Fully retract the conveyor
Complete all the above steps and record the success of the operation as "rate".
Measured: Immediately after marker placement
Operation time of Marker placement (in terms of marker placement)
Defined as starting from the time the marker conveyor is inserted into the bronchoscope until it is withdrew from the bronchoscope.
Measured: Immediately after marker placement
Operation time of marker release through bronchoscopy (in terms of marker placement)
Defined as starting from the time when the bronchoscope is inserted into the airway to the time when the marker conveyor is removed from the bronchoscope.
Measured: Immediately after marker placement
Operation time of exploration and removal of target lesion during VATS (in terms of marker placement)
Defined as starting lesion location exploration after the completion of preoperative surgical preparation and VATS access ports made, to the time of resection and removal of lung tissue.
Measured: Immediately after VATS
Safety: AEs (Adverse Events) and SAEs (Serious Adverse Events) occured during the clinical trial
AEs and SAEs occured from marker placement to 30days after the placement procedure.
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start22 Jul 2020
- Primary completion24 Dec 2020
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Broncus Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Qiu, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139408
- Sponsor's protocol ID
- BC-HM-01
- Status last verified
- May 2021
- First submitted
- 23 Oct 2019
- Last updated
- 19 May 2021
- Results posted
- 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 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Group Clinical Study to Evaluate the Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT04139408
- Acronym / sponsor ID
- BC-HM-01
- Conditions
- Lung Cancer
- Keywords
- Pulmonary Nodule, Localization, Marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hangzhou Broncus Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 25 Oct 2019 (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.
During the VATS procedure, some pulmonary nodules are relatively small or far away from the pleura, resulting that they are difficult to be accurately located during the procedure.
The aim of this study is to evaluate the efficacy and safety of using disposable pulmonary surgical markers to localize pulmonary nodules in subjects prior to the resection of pulmonary nodules by video-assisted thoracoscopic surgery (VATS).
Detailed description
It is a prospective, multicenter, single group target value clinical trial. The subjects will undergo VATS within 24h after the placement of the Marker, then the Marker and targeted nodule will be removed during VATS. Subjects will be followed up intraoperatively, immediately after placement procedure to the end of VATS resection, 7 days after placement procedure/before discharge (whichever occurs earlier), and 30 days after Marker placement procedure. Demographic and baseline information of subjects, immediate operation success rate of marker placement, positioning success rate, and adverse events will be collected and recorded in this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disposable Pulmonary Surgical Marker | Experimental | Device: Disposable Pulmonary Surgical MarkerLocate the pulmonary nodules with Disposable Pulmonary Surgical Marker before VATS. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-70 years old；
- Pulmonary nodule, which satisfying any of the following Criteria:
- Pulmonary wedge resection or Segmental pulmonary resection under VATS is proposed;
- Preoperative evaluation shows that placing marker through bronchus is feasible；
- The subject is able to fully understand the requirements of clinical research;
Key exclusion criteria (9 listed)
- Contraindications for bronchoscopy;
- Systemic factors: sepsis, history of repeated pulmonary infections, and any type of severe infectious disease within one month of screening；
- Severe cardio and pulmonary disease；
- Coagulation dysfunction, with a clear tendency to bleed;
- General anesthesia contraindication;
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 |
|---|---|---|
| Disposable Pulmonary Surgical MarkerThe subjects will undergo Marker placement procedure, within 24h before VATS. | Device | Disposable Pulmonary Surgical Marker |
Primary outcome
Positioning success rate
Time frame: Immediately after VATS
The proportion of patients who complete VATS resection of target pulmonary nodules/number of patients receiving localization of target pulmonary nodules before operation, expressed as "rate", will be evaluated during and immediately after surgery to evaluate the effectiveness of disposable pulmonary surgical markers in the localization of pulmonary nodules in surgery.
6 secondary outcomes
Positioning success rate (in terms of marker placement)
Time frame: Immediately after VATS
Immediate operation success rate of marker placement (in terms of marker, placement),including the following operations:
Time frame: Immediately after marker placement
Operation time of Marker placement (in terms of marker placement)
Time frame: Immediately after marker placement
Operation time of marker release through bronchoscopy (in terms of marker placement)
Time frame: Immediately after marker placement
Operation time of exploration and removal of target lesion during VATS (in terms of marker placement)
Time frame: Immediately after VATS
Safety: AEs (Adverse Events) and SAEs (Serious Adverse Events) occured during the clinical trial
Time frame: 30days
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 19 May 2021.
- 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.
Bin Qiu, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable Pulmonary Surgical Marker in people with Lung Cancer, run by Hangzhou Broncus Medical Co., Ltd. at 3 sites 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 9 inclusion and 9 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 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Positioning success rate (time frame: Immediately after VATS). 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 19 May 2021.