Pilot Study of the ACE System in Lung Procedures | NCT04651517

Studies
Pilot Study of the ACE System in Lung Procedures

NCT04651517

Sponsor

Xact Robotics Ltd.

Status

Completed

Last Update Posted

Aug 9, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Lung Diseases

Interventions

XACT ACE Robotics study arm

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 2021

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

Mar 15, 2021Actual

Primary Completion Date

Aug 3, 2021Actual

Completion Date

Aug 3, 2021Actual

First Submitted Date

Nov 17, 2020

First Submission Date that Met QC Criteria

Nov 25, 2020

First Posted Date

Dec 3, 2020Actual

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 5, 2021

Last Update Posted Date

Aug 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

To evaluate the XACT ACE Robotic System in lung procedures.

Detailed Description

The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous lung procedures. The system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking. This study will evaluate safety and accuracy of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures of the lung in the interventional radiology suite.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study arm	Experimental	Subjects undergoing procedures with the XACT ACE Robotic system.	Device: XACT ACE Robotics study arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XACT ACE Robotics study arm	Device	Subjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System.	Study arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events	Incidence, severity, and frequency of adverse events and device-related adverse events	30 days

Secondary Outcomes

Measure	Description	Time Frame
Secondary Performance Evaluation - Clinical Accuracy	Percent of procedures in which the needle reached the pre-defined target based on the physician's determination and CT imaging confirmation (clinical accuracy)	1 hour
Secondary Performance Evaluation - System Accuracy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age
Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor ablation, etc.
Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure
Subject is willing to sign informed consent
Subject is capable of adhering to study procedures

Exclusion Criteria:

Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart
Subject with significant coagulopathy
Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study
Subjects who are pregnant or nursing
Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sebastian Flacke, MD	Lahey Hospital & Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lahey Hospital and Medical Center		Burlington	Massachusetts	01805	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