Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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.

Bronchoscopic ablation catheter

Kelvin Lau, MA DPhil FRCS(CTh)

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.

The primary objective of this prospective, single-arm, multicenter, non-randomized study is to characterize the safety of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology device in subjects undergoing lung ablation procedures.

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

The following secondary endpoints will be evaluated:

* Composite rate of serious adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
* Composite rate of all adverse events related to the procedure or study devices through 1-month follow-up.
* Composite rate of all serious adverse events related to the procedure or study devices through 1-month follow-up.
* Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)
* Quality of life (EQ-5D Scale)
* Technical success
* Technique efficacy

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

Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using 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.

Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.

Rate of all AEs related to the procedure or study devices through 1-month follow-up.

Rate of all AEs related to the procedure or study devices through 1-month follow-up was also measured based on Common Terminology Criteria for Adverse Events (CTCAE) classification. CTCAE grading is evaluated on a scale from 1-5 (1 - mild; intervention not indicated; 5 - most severe; death related to AE). Subjects could have more than one AE with different CTCAE Grades.

Rate of all SAEs related to the procedure or study devices through 1-month follow-up.

Patient satisfaction, pain, and breathlessness (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)

At the 1-month visit, subjects assessed their pain/discomfort and breathlessness based on how they recall feeling at 3 different timepoints. The timepoints were immediately, one week, and one month after the bronchoscopic ablation procedure. Pain or discomfort were evaluated on a scale from 0-10 (10 - severe/interferes with basic needs). Breathlessness was evaluated on a scale from 1-5 (5 - too breathless to leave the house, or breathless when undressing).

Subjects also evaluated their willingness to have the procedure performed again on a scale from 1-5 (5 - extremely likely), how likely they would recommend the procedure to family and friends on a scale from 1-5 (5 - extremely likely), and how satisfied they were with the procedure on a scale from 1-5 (5 - extremely satisfied).

Quality of life evaluation based on EuroQol \[EQ-5D-3L\] survey. The questions from the survey surround current health status. The subjects assessed their current health state on a scale of 0-100 (100 being the best health state imaginable).

Technical success: An evaluation of whether the lung nodule was treated according to the study protocol as determined at the immediate post-procedural timepoint. This is in contrast to procedures in which the protocol could not be executed completely, either for technical reasons or for reasons related to comorbid disease.

Technique efficacy: An evaluation of whether the lung nodule was effectively ablated. Evaluates whether complete ablation of the nodule was achieved as evidenced by CT imaging follow-up 1-month post-procedure (including a window of 20-40 days post-procedure).

Medtronic - MITG

Adverse event definitions were based on ISO 14155:2011. All AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, or study procedures were required to be reported.

Observational NAVABLATE arm (single-arm study, no comparator)

NAVABLATE (Single-arm Study)

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Hong Kong

United Kingdom

Region of Enrollment

Chronic obstructive pulmonary disease

Tobacco use (current or former)

Lung surgery

Radiotherapy

Non-surgical biopsy procedure

Subjects could have more than one prior lung procedure performed.

Prior lung procedures performed

No prior lung procedure performed

Not a candidate for lung surgery or Stereotactic body radiation therapy (SBRT)

Declined both lung surgery and SBRT

Not a candidate for lung surgery and declined SBRT

Not a candidate for SBRT and declined lung surgery

Eligibility for Lung surgery or SBRT

State of cancer diagnosis

Nodule size (mm)

Lobe zone of nodule

Lobe location

Bronchus sign present based on pre-procedure CT scan

Bronchus sign present

Lesion morphology

30 subjects were enrolled. The bronchoscopic ablation procedure was performed on 1 lesion for each subject.

Julie Krzykowski

Observational NAVABLATE arm (single-arm, no comparator)

NAVABLATE (Single-Arm Study)

The number of participants analyzed includes subjects who were available at that time of analysis.

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

The number of participants analyzed includes subjects who were available at that time of analysis

Spots Global Cancer Trial Database for ablation, microwave