Clinical trial NCT03569111: Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter
Official title: Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Lung
Cancer, Metastatic to Lung
Keywords: Lung Nodule
Bronchoscopy
Ablation, Microwave
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
timeFrame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
Secondary outcomes:
measure: Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
timeFrame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
measure: Number of Participants With AEs Related to Study Procedure or Study Devices
timeFrame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
measure: Number of Participants With SAEs Related to the Study Procedure or Study Devices
timeFrame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
measure: Score of Patient Satisfaction, Pain, and Breathlessness
timeFrame: 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)
measure: Score of Current Health State From Quality of Life Survey
timeFrame: Baseline and 1-month
measure: Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol
timeFrame: Immediately post-procedure
measure: Number of Lung Nodules Evaluated as Being Effectively Ablated
timeFrame: 1-month follow-up (an average of 20-40 days post-procedure)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
Study officials:
affiliation: St Bartholomew's Hosptial
name: Kelvin Lau, MA DPhil FRCS(CTh)
role: PRINCIPAL_INVESTIGATOR
References: