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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569111
Recruitment Status : Completed
First Posted : June 26, 2018
Results First Posted : November 15, 2022
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Description
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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.


Condition or disease Intervention/treatment
Cancer, Lung Cancer, Metastatic to Lung Device: Bronchoscopic ablation catheter

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
Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
Actual Study Start Date : February 27, 2019
Actual Primary Completion Date : October 28, 2020
Actual Study Completion Date : October 28, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Bronchoscopic 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.

Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology [ Time Frame: 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 Outcome Measures :
  1. Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology [ Time Frame: 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.

  2. Number of Participants With AEs Related to Study Procedure or Study Devices [ Time Frame: 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.


  3. Number of Participants With SAEs Related to the Study Procedure or Study Devices [ Time Frame: 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.

  4. Score of Patient Satisfaction, Pain, and Breathlessness [ Time Frame: 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).


  5. Score of Current Health State From Quality of Life Survey [ Time Frame: 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).

  6. Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol [ Time Frame: 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.

  7. Number of Lung Nodules Evaluated as Being Effectively Ablated [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569111


Locations
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Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
United Kingdom
St. Bartholomew's Hospital
London, United Kingdom
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Kelvin Lau, MA DPhil FRCS(CTh) St Bartholomew's Hosptial
  Study Documents (Full-Text)

Documents provided by Medtronic - MITG:
Study Protocol and Informed Consent Form  [PDF] September 26, 2019
Statistical Analysis Plan  [PDF] September 26, 2018

More Information
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03569111    
Other Study ID Numbers: MDT18010ILSBA
First Posted: June 26, 2018    Key Record Dates
Results First Posted: November 15, 2022
Last Update Posted: November 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medtronic - MITG:
Lung Nodule
Bronchoscopy
Ablation, Microwave
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases