The primary objective of this Clinical Investigation is to evaluate the diagnostic yield using the Ion Endoluminal System when used with adjunctive 3D imaging modalities for the biopsy of peripheral pulmonary nodules (PPNs). In a first phase, the…
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary performance endpoint:
- Diagnostic yield of sample(s) obtained (post learning curve)
- Sensitivity CUSUM analysis (learning curve)
Secondary outcome
Secondary performance endpoint:
- Sensitivity for malignancy of sample(s) obtained
- Rate of achieving biopsy tool position within the targeted nodule(s) as
confirmed by CBCT 3D imaging or the combination of multi-angle augmented
fluoroscopy with rEBUS and diagnostic rapid onsite pathology (in the absence of
a confirmatory spin).
Safety endpoint:
- Rate of procedure-related Adverse Events through 7 days post-procedure
Exploratory endpoint:
- Procedure-related characteristics:
o Total number of imaging spins to obtain Tool in Nodule(s) as defined above
o Number of catheter readjustments required to obtain Tool in Nodule(s)
o Tool to nodule spatial relationship
o Duration-related outcomes:
- procedure time (from catheter inserted into the patient*s airways to
catheter removed from the patient*s airways)
- navigation time
- time to rEBUS visualization
- biopsy time
o Number of additional interventional diagnostic procedures required post-
procedure for a definitive diagnosis of the target nodule(s)
o rEBUS visualization characteristics
o Biopsy workflow, including but not limited to, sequence of biopsy tools used
Background summary
According to 2020 estimates by the International Agency for Research on Cancer
and World Health Organization, the incidence of lung cancer worldwide
represents 11.4% of all cancers diagnosed, and the mortality rate due to lung
cancer was as high as 18% of all cancer-related deaths. Besides the aggressive
nature of lung cancer, its high mortality is mainly attributed to the delay
between symptom presentation and cancer progression. Late detection of lung
cancer can cause the pulmonary nodule to continue to grow and spread to other
parts of the lung, leading to potential metastasis to other parts of the body
before any symptoms are observed. Therefore, rapid identification of pulmonary
nodules is a critical challenge that needs to be addressed for early diagnosis
of lung cancer. Despite the development of guided-bronchoscopy including
virtual bronchoscopy, and electromagnetic navigation, the diagnostic yield
remains lower than that of image guided transthoracic needle aspiration [13].
The study device, through its uniquely designed catheter with shape-sensing
technology and small outer diameter, can reach peripheral airways to provide
the physician the ability to potentially improve biopsy sampling for small
nodules. This Clinical Investigation was designed to evaluate the learning
curve and diagnostic yield of using the Ion Endoluminal System when used with
adjunctive 3D imaging modalities for biopsy of peripheral pulmonary nodule(s)
and to evaluate the rate of Tool in Nodule(s), the procedural characteristics
and diagnostic characteristics of the sample obtained by the Ion Endoluminal
System.
[13] Agrawal, A., D.K. Hogarth, and S. Murgu, Robotic bronchoscopy for
pulmonary lesions: a review of existing technologies and clinical data. J
Thorac Dis, 2020. 12(6): p. 3279- 3286.
Study objective
The primary objective of this Clinical Investigation is to evaluate the
diagnostic yield using the Ion Endoluminal System when used with adjunctive 3D
imaging modalities for the biopsy of peripheral pulmonary nodules (PPNs).
In a first phase, the learning curve of the procedure will be retrospectively
assessed using CUSUM analysis. In a second phase (after having concluded that
the initial learning curve has passed), the diagnostic characteristics (e.g.
diagnostic yield and accuracy) is further evaluated through a prospective pilot
study. The included patients and lesions are propensity score matched to an
available database of CBCT-guided navigation bronchoscopy procedures as
routinely performed in the Radboudumc for comparison.
The secondary objective of this Clinical Investigation is to evaluate
procedural characteristics and diagnostic characteristics of the sample(s)
obtained by the Ion Endoluminal System.
Study design
A prospective, dual-arm, interventional study.
Prospective collection of consecutive patients undergoing a biopsy procedure
with the Ion Endoluminal system with CBCT imaging, and comparing these results
with the prospectively collected cohort of CBCT-navigation bronchoscopy
procedures performed at Radboudumc.
Intervention
Patients with peripheral pulmonary nodule(s) measuring >=6 mm and <=3 cm in
largest dimension (based on pre-procedure CT scan) who are indicated to undergo
bronchoscopic biopsy for lung nodule(s) of unknown etiology, suspicious for
primary lung cancer or metastatic disease will undergo Robotic Navigational
Bronchoscopy.
Study burden and risks
Risk management activities reduced the degree of potential risks through risk
control measures for the study device, but residual risks remained
(Investigator*s Brochure). A range of adverse events could occur depending upon
the severity of the injury and the timing of its identification. The harms
related to the study device range from no adverse health consequences up to and
including critical, related to pneumothorax requiring intervention,
biocompatibility/cytotoxic response, infection, procedural delays and toxic
reaction from foreign body. The probability of severe adverse events is
extremely low given the multiple mitigations. Various high-residual-risk items
for the study device have been described in terms of likelihood and severity of
adverse events, such as pneumothorax and bleeding. Refer to the investigator
brochure for the complete list of foreseeable adverse device events.
In light of the potential clinical benefits, and measures for risk mitigation,
we conclude that the benefits of lung biopsy using the investigational study
device outweigh the potential risks. Refer to the Investigator*s Brochure for
comprehensive list for risk mitigation.
Risks associated with bronchoscopic lung biopsy procedures under general
anesthesia are usually minor and transient. Also, serious adverse events may
occur. There may also be risks associated with the use of general anesthesia or
an endotracheal tube, which are not specific to the investigational procedure.
For the risks and benefits of the investigational device, clinical procedure
and clinical investigation refer to chapter 5 of the CIP.
Kifer Road 1020
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Kifer Road 1020
Sunnyvale CA 94086
US
Listed location countries
Age
Inclusion criteria
1. Patient is aged 18 years or older at time of consent.
2. Patient is suitable for elective nodule biopsy via bronchoscopy under
general anesthesia per Investigator*s discretion.
3. Patient has solid or semi-solid pulmonary nodule(s) of >=6 mm and <=3 cm in
largest dimension (based on pre-procedure CT scan).
4. Pulmonary nodule(s) intended for biopsy during the study procedure is (are)
located at least 4 (>=4) airway generations out (trachea = generation 0, e.g.
subsegmental bronchi or beyond) based on pre-procedure CT scan.
5. Patient has a moderate to high risk of lung cancer based on clinical,
demographic, and radiologic information or with suspected metastatic disease.
High risk for malignancy patients are eligible if a biopsy is required or
requested prior to intervention.
6. Patient is willing and able to give written informed consent for Clinical
Investigation participation.
7. Patient is not legally incapacitated or in a legal/court ordered
institution.
Exclusion criteria
1. Patient has a lack of fitness or exercise capacity to undergo bronchoscopy
under general anesthesia as determined by Investigator prior to procedure.
2. Patient with type 1 pure ground glass opacity target nodule(s) for biopsy
during study procedure.
3. Presence of bullae(s) with a size of > 1 cm on pre-procedure CT scan located
in close proximity to target nodule(s) and near the planned trajectory of the
biopsy instruments.
4. Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan.
5. Patient with ASA >=4.
6. Patient underwent a pneumonectomy.
7. Any invasive concomitant procedure (outside of lymph node staging) not
related to the pulmonary nodule(s) or suspected disease state.
8. Female patient of child-bearing potential who is unable to take adequate
contraceptive precautions or is known to be pregnant, and/or breast feeding.
9. Patient has a documented medical history of uncorrectable coagulopathy,
bleeding, or platelet disorder.
10. Patient is taking antiplatelet or anticoagulant medications that cannot be
stopped per standard practice.
11. Patient is currently participating or has participated in another Clinical
Investigation within the past 30 days, such as interventional trials or trials
with experimental agents or agents of unknown risk, that may affect the
endpoints of this Clinical Investigation.
12. Investigator, in their professional opinion, has decided that it is in the
patient*s best interest to not participate in the Clinical Investigation.
13. Patient is not willing to comply with post study procedure participation
requirements.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79689.091.23 |