NEUWAVE Flexible Probe Study #2

NCT03713099 | Withdrawn FDA Device

• 1 other identifier: NEU_2018_01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

Patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung will have transbronchial microwave ablation performed using cone beam CT for probe guidance and confirmation.

Conditions

Cancer of the Lung; Lung Cancer; Neoplasms, Lung; Carcinoma, Non-Small Cell Lung; Non-Small Cell Lung Cancer; Non-Small Cell Lung Carcinoma

Keywords

Microwave Ablation

Outcome Measures

Primary Outcomes (3)

• Device User Experience Survey

  The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the NEUWAVE microwave ablation system. The questionnaire asks approximately 30 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating physician at the completion of each ablation. A summary of all treating physician responses will be generated at the completion of the study to summarize the overall user experience with the device.

  Day of ablation (day 0)

• Technical Success (lesion completely ablated)

  Technical Success is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, immediately following the ablation procedure.

  Day of ablation (day 0)

• Technique Efficacy (lesion completely ablated)

  Technique Efficacy is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, at Visit 3 (i.e. 30 days post-ablation).

  30 days post-ablation

Secondary Outcomes (6)

• Adverse Events

  1 year post-ablation

• Primary Efficacy Rate

  Day of ablation (day 0)

• Secondary Efficacy Rate

  1 year post-ablation

• Target Lesion Recurrence

  1 year post-ablation

• Length of Hospital Stay

  Day of ablation (day 0)

Other Outcomes (3)

• EORTC QLQ-C30

  1 year post-ablation

• EORTC QLQ-LC13

  1 year post-ablation

• Numeric Pain Scale

  30 days post-ablation

Study Arms (1)

Microwave Ablation

EXPERIMENTAL

Microwave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon.

Device: Microwave ablation

Interventions

Microwave ablation DEVICE

Microwave ablations will be performed under general anesthesia via a transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound (EBUS) to confirm disease staging.

Microwave Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Patients greater or equal to 18 years of age
• Performance status 0-2 (Eastern Cooperative Oncology Group classification \[ECOG\])
• Willing to fulfill all follow-up visit requirements
• Medically inoperable and operable secondary soft tissue lesion(s) of the lung
• A maximum of two ipsilateral soft tissue lesions less than or equal to 2cm in the outer two-thirds of the lung and not closer than 1cm to the pleura. Lesion size must be measured with at least 2-dimensional imaging.

You may not qualify if:

• Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related
• Pregnant or breastfeeding
• Physical or psychological condition that would impair study participation
• Patients with uncorrectable coagulopathy at the time of screening
• Patient with implantable devices, including pacemakers or other electronic implants
• Prior pneumonectomy or bronchiectasis
• Severe neuromuscular disease
• Patient count less than or equal to 50,000/mm cubed
• ASA (American Society of Anesthesiologists) score of greater than or equal to 4
• Inability to tolerate anesthesia
• Expected survival less than 6 months
• Clinically significant hypertension
• Chronic, continuous ventilator support, which uses bi-level positive airway pressure (PAP) to improve lung function for severe conditions (however, intermittent PAP, for non-pulmonary conditions, such as sleep apnea, is permitted)
• Endobronchial soft tissue lesions proximal to the segmental airways
• Imaging findings of active pulmonary infection

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York Presbyterian-Weill Cornell Medicine

New York, New York, 10065, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 19, 2018
• Study Start: July 31, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: June 2, 2020

Record last verified: 2020-05

Locations

US (5)