Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter

NCT03569111 | Completed Results

• 1 other identifier: MDT18010ILSBA
• Study Type: observational
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this investigation is to characterize the safety and performance of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology in clinical use. This is a prospective, single-arm, multicenter, non-randomized study. Up to 3 sites in up to 3 countries will enroll up to 30 subjects in total. The study is designed to characterize the safety and performance of the bronchoscopic ablation procedure using the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology.

Conditions

Cancer, Lung; Cancer, Metastatic to Lung

Keywords

Lung Nodule; Bronchoscopy; Ablation, Microwave

Outcome Measures

Primary Outcomes (1)

• Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology

  The primary endpoint is the rate of adverse events (AEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.

  During procedure through 1-month follow-up (an average of 20-40 days post-procedure)

Secondary Outcomes (7)

• Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology

  During procedure through 1-month follow-up (an average of 20-40 days post-procedure)

• Number of Participants With AEs Related to Study Procedure or Study Devices

  During procedure through 1-month follow-up (an average of 20-40 days post-procedure)

• Number of Participants With SAEs Related to the Study Procedure or Study Devices

  During procedure through 1-month follow-up (an average of 20-40 days post-procedure)

• Score of Patient Satisfaction, Pain, and Breathlessness

  Immediately following the procedure, 1 week post-procedure, 1-month post-procedure; all were collected at the 1-month follow-up visit (20-40 days post-procedure)

• Score of Current Health State From Quality of Life Survey

  Baseline and 1-month

Interventions

Bronchoscopic ablation catheter DEVICE

The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is deployed endoscopically and will be used to conduct bronchoscopic ablations in the lung using the superDimension™ navigation system.

Eligibility Criteria

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

Study Population

Subjects included must have a cancerous lung nodule, and will be candidates for an elective ENB and lung ablation procedure. Subjects themselves will need to provide written consent and agree to attend study visits and complete questionnaires. Up to 30 subjects will be enrolled in this study.

You may qualify if:

• Subject is ≥ 18 years of age
• Subject has provided informed consent
• Subject is able and willing to comply with the study follow-up schedule
• Subject has a definitive diagnosis of cancer in the lung
• Target nodule is ≤ 30mm in maximum diameter
• There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure
• Subject is a candidate for an elective electromagnetic navigation bronchoscopy (ENB) procedure
• Subject is a candidate for an elective lung ablation procedure according to standard of care and product Instructions for Use
• Subject is not a candidate for lung surgery or refuses lung surgery
• Subject is not a candidate for stereotactic body radiation therapy (SBRT) or refuses SBRT

You may not qualify if:

• Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
• Patients currently diagnosed with Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage IV emphysema
• Female subjects who are pregnant or nursing as determined by standard site practices
• Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
• The investigator determines that participation in the study may jeopardize the safety or welfare of the subject

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (2)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

St. Bartholomew's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Julie Krzykowski
• Organization: Medtronic

Julie.Krzykowski@Medtronic.com

763-202-3325

Study Officials

• Kelvin Lau, MA DPhil FRCS(CTh)

  St Bartholomew's Hosptial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: February 27, 2019
• Primary Completion: October 28, 2020
• Study Completion: October 28, 2020
• Last Updated: November 15, 2022
• Results First Posted: November 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); HK (1)