Prospective Post-market Data Collection for Ion Endolumin... | NCT04735341

Studies
Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence

NCT04735341

Sponsor

Intuitive Surgical

Status

Completed

Last Update Posted

Aug 9, 2022Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Lung Cancer
Pulmonary Nodule, Solitary

Interventions

Ion Endoluminal System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2020Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Jan 28, 2021

First Submission Date that Met QC Criteria

Feb 2, 2021

First Posted Date

Feb 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2022

Last Update Posted Date

Aug 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects with planned Ion Endoluminal Procedure with pulmonary nodule			Device: Ion Endoluminal System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ion Endoluminal System	Device	Ion Endoluminal Procedure for pulmonary nodule	Subjects with planned Ion Endoluminal Procedure with pulmonary nodule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ion Catheter Shape	The collection of data relating to the Ion catheter shape	Intra-operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of 18 years or older
- Undergoing a lung biopsy procedure with Ion System
- Have peripheral pulmonary lesion (5th bronchial generation or higher)
- Willingness to participate as demonstrated by signing the informed consent

Exclusion Criteria:

Unable to provide informed consent
- Presence of bilateral nodules intended to be biopsied during procedure
- The presence of medical conditions contraindicating general anesthesia or bronchoscopic biopsy
- Vulnerable population (e.g., prisoners, mentally disabled)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who will undergo an Ion Endoluminal Procedure with a pulmonary nodule, 18 years or older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FirstHealth of the Carolinas Moore Regional Hospital		Pinehurst	North Carolina	28374	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D003074	Solitary Pulmonary Nodule

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided