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

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ClinicalTrials.gov Identifier: NCT03569111
Recruitment Status : Not yet recruiting
First Posted : June 26, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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 Type : Observational
Estimated 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
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine



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.


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).



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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

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


Contacts
Contact: Jennifer J Wolvers +1.763.258.9405 Jennifer.Wolvers@Medtronic.com

Locations
Hong Kong
Prince of Wales Hospital Not yet recruiting
Hong Kong, Hong Kong
Contact: Calvin Ng, MD         
United Kingdom
St. Bartholomew's Hospital
London, United Kingdom
Sponsors and Collaborators
Medtronic - MITG
Investigators
Principal Investigator: Kelvin Lau, MA DPhil FRCS(CTh) St Bartholomew's Hosptial

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03569111     History of Changes
Other Study ID Numbers: MDT18010ILSBA
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases