Pilot Study of the ACE System in Lung Procedures

NCT04651517 | Completed FDA Device

• 1 other identifier: CLIN-LUNG-01-2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the XACT ACE Robotic System in lung procedures.

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Incidence, severity, and frequency of adverse events and device-related adverse events

  30 days

Secondary Outcomes (2)

• Secondary Performance Evaluation - Clinical Accuracy

  1 hour

• Secondary Performance Evaluation - System Accuracy

  1 hour

Study Arms (1)

Study arm

EXPERIMENTAL

Subjects undergoing procedures with the XACT ACE Robotic system.

Device: XACT ACE Robotics study arm

Interventions

XACT ACE Robotics study arm DEVICE

Subjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System.

Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Xact Robotics Ltd.: lead

Study Sites (1)

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Sebastian Flacke, MD

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects 18 years of age or older who are undergoing CT guided, minimally invasive percutaneous procedures of the lung.

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 3, 2020
• Study Start: March 15, 2021
• Primary Completion: August 3, 2021
• Study Completion: August 3, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)