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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03569111

Acronym

NAVABLATE

Enrollment

Registered

2018-06-26

Start date

2019-02-27

Completion date

2020-10-28

Last updated

2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Lung, Cancer, Metastatic to Lung

Keywords

Lung Nodule, Bronchoscopy, Ablation, Microwave

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.

Detailed description

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

Interventions

DEVICEBronchoscopic ablation catheter

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subject is ≥ 18 years of age 2. Subject has provided informed consent 3. Subject is able and willing to comply with the study follow-up schedule 4. Subject has a definitive diagnosis of cancer in the lung 5. Target nodule is ≤ 30mm in maximum diameter 6. There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure 7. Subject is a candidate for an elective electromagnetic navigation bronchoscopy (ENB) procedure 8. Subject is a candidate for an elective lung ablation procedure according to standard of care and product Instructions for Use 9. Subject is not a candidate for lung surgery or refuses lung surgery 10. Subject is not a candidate for stereotactic body radiation therapy (SBRT) or refuses SBRT

Exclusion criteria

1. Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea 2. Patients currently diagnosed with Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage IV emphysema 3. Female subjects who are pregnant or nursing as determined by standard site practices 4. Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study 5. The investigator determines that participation in the study may jeopardize the safety or welfare of the subject

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With AEs 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)	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.

Secondary

Measure	Time frame	Description
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)	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.
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)	Rate of all SAEs related to the procedure or study devices through 1-month follow-up.
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)	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).
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)	Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol	Immediately post-procedure	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.
Number of Lung Nodules Evaluated as Being Effectively Ablated	1-month follow-up (an average of 20-40 days post-procedure)	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).
Score of Current Health State From Quality of Life Survey	Baseline and 1-month	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).

Countries

Hong Kong, United Kingdom

Participant flow

Participants by arm

Arm	Count
NAVABLATE (Single-arm Study) Observational NAVABLATE arm (single-arm study, no comparator)	30
NAVABLATE (Single-arm Study) Observational NAVABLATE arm (single-arm study, no comparator)	30
Total	60

Baseline characteristics

Characteristic	NAVABLATE (Single-arm Study)
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	19 Participants
Age, Categorical Between 18 and 65 years	11 Participants
Age, Continuous	68.4 Years STANDARD_DEVIATION 10.3
Bronchus sign present	14 Participants
Chronic obstructive pulmonary disease	10 Participants
Eligibility for Lung surgery or SBRT Declined both lung surgery and SBRT	10 Participants
Eligibility for Lung surgery or SBRT Not a candidate for lung surgery and declined SBRT	5 Participants
Eligibility for Lung surgery or SBRT Not a candidate for lung surgery or Stereotactic body radiation therapy (SBRT)	14 Participants
Eligibility for Lung surgery or SBRT Not a candidate for SBRT and declined lung surgery	1 Participants
Lesion morphology Suzuki class 1 or 2 (Pure Ground Glass Opacity [GGO] or Mostly GGO)	3 Lesions
Lesion morphology Suzuki class 3 or 4 (Halo or Mixed)	5 Lesions
Lesion morphology Suzuki class 5 or 6 (Solid Pattern with GGO or Solid)	22 Lesions
Lobe location Left Lower Lobe	4 Participants
Lobe location Left Upper Lobe	6 Participants
Lobe location Right Lower Lobe	8 Participants
Lobe location Right Middle Lobe	2 Participants
Lobe location Right Upper Lobe	10 Participants
Lobe zone of nodule Middle third of lung	11 Lesions
Lobe zone of nodule Peripheral third of lung	19 Lesions
Lobe zone of nodule Proximal third of lung	0 Lesions
Nodule size (mm)	13.7 millimeters STANDARD_DEVIATION 5.3
No prior lung procedure performed	7 Participants
Prior lung procedures performed Lung surgery	11 Participants
Prior lung procedures performed Non-surgical biopsy procedure	19 Participants
Prior lung procedures performed Radiotherapy	1 Participants
Region of Enrollment Hong Kong	14 Participants
Region of Enrollment United Kingdom	16 Participants
Sex: Female, Male Female	12 Participants
Sex: Female, Male Male	18 Participants
State of cancer diagnosis Oligometastatic	10 Participants
State of cancer diagnosis Primary Lung Cancer	20 Participants
Tobacco use (current or former)	20 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 30
other Total, other adverse events	20 / 30
serious Total, serious adverse events	4 / 30

Outcome results

Primary

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.

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

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
NAVABLATE (Single-Arm Study)	Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology	1 Participants

Secondary

Number of Lung Nodules Evaluated as Being Effectively Ablated

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).

Time frame: 1-month follow-up (an average of 20-40 days post-procedure)