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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 : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : October 6, 2020
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
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

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. Characterize the safety of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology (AEs related to study device) [ Time Frame: 1-month ]
    The primary endpoint is the composite rate of adverse events (AEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.


Secondary Outcome Measures :
  1. SAEs related to study device [ Time Frame: 1-month ]
    Composite rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.

  2. AEs related to study procedure [ Time Frame: 1-month ]
    Composite rate of all AEs related to the procedure or study devices through 1-month follow-up.

  3. SAEs related to study procedure [ Time Frame: 1-month ]
    Composite rate of all SAEs related to the procedure or study devices through 1-month follow-up.

  4. Patient Survey [ Time Frame: 1-month ]
    Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)

  5. Quality of Life (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression, health state) [ Time Frame: 1-month ]

    Quality of life evaluation (EuroQol [EQ-5D]). The questions from the survey surround current health status. There are 5 questions where the response options get worse as they go in regards to different aspects of the subject's health status.

    The last question asks on a scale of 0-100, the current health state (100 being the best health state imaginable)


  6. Technical Success [ Time Frame: 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. Technique Efficacy [ Time Frame: 1-month ]
    Technique efficacy: An evaluation of whether the lung nodule was effectively ablated. Evaluates whether complete ablation of the nodule was achieved as evidenced by 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
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
Last Update Posted: October 6, 2020
Last Verified: October 2020
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