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Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology (TiLT)

Primary Purpose

Lung Cancer, Nodes, Lung

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Robotic assisted bronchoscopy
Sponsored by
Noah Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Lung cancer, robotic assisted bronchoscopy

Eligibility Criteria

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

Inclusion Criteria: Age ≥ 18 Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information, determined by the treating physicians based on the site's standard of care Peripheral pulmonary subsolid and solid nodules (PPNs) sized 1-3 cm measured as the largest dimension where all or the majority of the lesion is located in the periphery of the lung Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure PPNs that are accessible bronchoscopically on planning CT reconstruction Informed consent properly obtained per local regulations Exclusion Criteria: Known pregnancy or breastfeeding Patients with pure ground-glass nodules on pre-procedural chest CT Uncontrolled coagulopathy or bleeding disorders Ongoing systemic infection History of lobectomy or pneumonectomy Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days. Moderate-to-severe hypoxia, hypoxemia, or hypercarbia per PI's discretion Patients with pacemakers or defibrillators Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist

Sites / Locations

  • Chinese University of Hong Kong, Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robotic assisted bronchoscopy

Arm Description

Robotic assisted bronchoscopy procedures performed using the Galaxy System.

Outcomes

Primary Outcome Measures

Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Successful navigation of the tool in lesion using the Galaxy System's TiLT technology will be confirmed using Cone Beam Computed Tomography (CBCT) prior to biopsies being performed.
Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure
Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.

Secondary Outcome Measures

Diagnostic yield
Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue.
Center strike as confirmed by CBCT
Number of patients that the tool was confirmed to be in the center of the lesion prior to biopsy.

Full Information

First Posted
September 20, 2023
Last Updated
September 26, 2023
Sponsor
Noah Medical
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1. Study Identification

Unique Protocol Identification Number
NCT06056128
Brief Title
Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology
Acronym
TiLT
Official Title
Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology in Human Subjects to Bronchoscopically Biopsy Small Peripheral Pulmonary Nodules: TiLT Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noah Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Detailed Description
Successful biopsy of peripheral pulmonary lesions continues to be a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, investigators will evaluate the feasibility of the Galaxy System, which uses a built-in real-time navigation system called TiLT Technology, to both access and biopsy peripheral pulmonary lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Nodes, Lung
Keywords
Lung cancer, robotic assisted bronchoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic assisted bronchoscopy
Arm Type
Experimental
Arm Description
Robotic assisted bronchoscopy procedures performed using the Galaxy System.
Intervention Type
Device
Intervention Name(s)
Robotic assisted bronchoscopy
Intervention Description
Robotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions
Primary Outcome Measure Information:
Title
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Description
Successful navigation of the tool in lesion using the Galaxy System's TiLT technology will be confirmed using Cone Beam Computed Tomography (CBCT) prior to biopsies being performed.
Time Frame
During the procedure
Title
Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure
Description
Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
Time Frame
Up to 7 days post-procedure
Secondary Outcome Measure Information:
Title
Diagnostic yield
Description
Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue.
Time Frame
Between 7 days and 6 months post-procedure
Title
Center strike as confirmed by CBCT
Description
Number of patients that the tool was confirmed to be in the center of the lesion prior to biopsy.
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information, determined by the treating physicians based on the site's standard of care Peripheral pulmonary subsolid and solid nodules (PPNs) sized 1-3 cm measured as the largest dimension where all or the majority of the lesion is located in the periphery of the lung Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure PPNs that are accessible bronchoscopically on planning CT reconstruction Informed consent properly obtained per local regulations Exclusion Criteria: Known pregnancy or breastfeeding Patients with pure ground-glass nodules on pre-procedural chest CT Uncontrolled coagulopathy or bleeding disorders Ongoing systemic infection History of lobectomy or pneumonectomy Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days. Moderate-to-severe hypoxia, hypoxemia, or hypercarbia per PI's discretion Patients with pacemakers or defibrillators Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ami Shah
Phone
9253390606
Email
amishah@noahmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Song Liu
Phone
9253390606
Email
songliu@noahmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Calvin Ng, MD
Organizational Affiliation
Chinese University of Hong Kong, Prince of Wales Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese University of Hong Kong, Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Calvin Ng, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology

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