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Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging
Sponsored by
Intuitive Surgical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Lung cancer, Biopsy, Bronchoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is aged 18 years or older at time of consent. Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion. Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan). 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. 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. Patient is willing and able to give written informed consent for Clinical Investigation participation. Patient is not legally incapacitated or in a legal/court ordered institution. Exclusion Criteria: Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure. Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure. 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. Presence of mediastinal nodal disease on pre-procedure CT or positron emission tomography (PET)-CT scan. Patient with American Society of Anesthesiologists Classification (ASA) ≥4. Patient underwent a pneumonectomy. Any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule(s) or suspected disease state. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice. 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. Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation. Patient is not willing to comply with post study procedure participation requirements.

Sites / Locations

  • Barts Health Nhs TrustRecruiting
  • Royal Brompton & Harefield Hospitals, Part of Guy'S and St Thomas' Nhs Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biopsy Arm

Arm Description

Patients undergoing biopsy with the Ion Endoluminal System

Outcomes

Primary Outcome Measures

Tool in Nodule
Rate of achieving biopsy tool position within the targeted nodule(s) Defined as how often the biopsy needle used to sample the tissue is positioned directly within the nodule before the sample is taken. If biopsy forceps are used, it is how often the instrument is surrounding the nodule before the sample is taken

Secondary Outcome Measures

Diagnostic accuracy of sample(s) obtained
Diagnostic accuracy will be calculated as the rate of diagnosis made using samples obtained during the study procedure (true positives and true negatives) relative to the number of cases performed. Diagnostic yield may also be reported in conjunction with diagnostic accuracy and calculated as the rate of malignant and benign diagnosis made relative to the number of cases performed; non-diagnostic samples will not be included in the numerator.
Sensitivity for malignancy of sample(s) obtained
Sensitivity for malignancy of samples is assessed as the number of subjects with a malignant condition determined through the study procedure (true positives) relative to the number of subjects with an underlying malignant disease state (true positives + false negatives). The subjects underlying disease state will be determined by follow-up diagnostic interventions or treatment decisions/interventions, and/or radiographic follow-up.

Full Information

First Posted
April 21, 2023
Last Updated
July 28, 2023
Sponsor
Intuitive Surgical
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1. Study Identification

Unique Protocol Identification Number
NCT05867953
Brief Title
Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System
Official Title
A Prospective Investigation to Assess the Accurate Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System With Adjunct Real-time Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuitive Surgical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this research study is to evaluate the effectiveness of the ION endoluminal system at reaching and obtaining biopsies from lung nodules when used in combination with 3-dimensional imaging such as CT scans. Data on safety will also be collected.
Detailed Description
This is a prospective, interventional, multicentre, single arm study which will be conducted in Europe and will involve up to 200 patients undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with 3D imaging. The objectives of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including rate of tool in nodule, diagnostic accuracy, sensitivity for malignancy and safety. All subjects will be followed up at 1 week and 1 month after the procedure. If the biopsy did not provide a diagnosis or did not show cancer, then they will have further follow up at 6 and 13 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, Biopsy, Bronchoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, multi-center, single-arm, interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biopsy Arm
Arm Type
Experimental
Arm Description
Patients undergoing biopsy with the Ion Endoluminal System
Intervention Type
Device
Intervention Name(s)
Biopsy with the Robotic- Ion Endoluminal System with Adjunct Real-time Imaging
Intervention Description
Biopsy with the Robotic- Navigational Bronchoscopy System with Adjunct Real-time Imaging
Primary Outcome Measure Information:
Title
Tool in Nodule
Description
Rate of achieving biopsy tool position within the targeted nodule(s) Defined as how often the biopsy needle used to sample the tissue is positioned directly within the nodule before the sample is taken. If biopsy forceps are used, it is how often the instrument is surrounding the nodule before the sample is taken
Time Frame
At time of the biopsy procedure (Day 0)
Secondary Outcome Measure Information:
Title
Diagnostic accuracy of sample(s) obtained
Description
Diagnostic accuracy will be calculated as the rate of diagnosis made using samples obtained during the study procedure (true positives and true negatives) relative to the number of cases performed. Diagnostic yield may also be reported in conjunction with diagnostic accuracy and calculated as the rate of malignant and benign diagnosis made relative to the number of cases performed; non-diagnostic samples will not be included in the numerator.
Time Frame
Up to 13 months post procedure
Title
Sensitivity for malignancy of sample(s) obtained
Description
Sensitivity for malignancy of samples is assessed as the number of subjects with a malignant condition determined through the study procedure (true positives) relative to the number of subjects with an underlying malignant disease state (true positives + false negatives). The subjects underlying disease state will be determined by follow-up diagnostic interventions or treatment decisions/interventions, and/or radiographic follow-up.
Time Frame
Up to 13 months post procedure
Other Pre-specified Outcome Measures:
Title
Rate of procedure-related Adverse Events through 30 days post-procedure
Description
The study's safety endpoint is the rate of procedure-related Adverse Events through 30 days post-procedure
Time Frame
30 days
Title
Exploratory endpoint 1: Procedure-related characteristics
Description
Procedure time (from catheter inserted into the patient's airways to catheter removed from the patient's airways) will be reported.
Time Frame
At time of the biopsy procedure (Day 0)
Title
Exploratory endpoint 2:rEBUS visualization characteristics
Description
The frequency of rEBUS visualization view during the biopsy will be summarized.
Time Frame
At time of the biopsy procedure (Day 0)
Title
Exploratory endpoint 3: Biopsy workflow
Description
The sequence of biopsy tools used will be summarized.
Time Frame
At time of the biopsy procedure (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is aged 18 years or older at time of consent. Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion. Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan). 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. 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. Patient is willing and able to give written informed consent for Clinical Investigation participation. Patient is not legally incapacitated or in a legal/court ordered institution. Exclusion Criteria: Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure. Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure. 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. Presence of mediastinal nodal disease on pre-procedure CT or positron emission tomography (PET)-CT scan. Patient with American Society of Anesthesiologists Classification (ASA) ≥4. Patient underwent a pneumonectomy. Any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule(s) or suspected disease state. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice. 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. Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation. Patient is not willing to comply with post study procedure participation requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carine Van den Abeele
Phone
+41 79 656 95 48
Email
Carine.vandenabeele@intusurg.com
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Bean
Phone
+49 172 899 4278
Email
Martha.Bean@intusurg.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sundeep Master
Organizational Affiliation
Intuitive Surgical
Official's Role
Study Director
Facility Information:
Facility Name
Barts Health Nhs Trust
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacquline South
Email
jacquline.south@nhs.net
First Name & Middle Initial & Last Name & Degree
Kelvin KW Lau
Facility Name
Royal Brompton & Harefield Hospitals, Part of Guy'S and St Thomas' Nhs Foundation Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ley T Chan
Email
l.chan3@rbht.nhs.uk
First Name & Middle Initial & Last Name & Degree
Pallav L Shah
First Name & Middle Initial & Last Name & Degree
Chris M Orton

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System

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