NEUWAVE Flexible Probe Study #2

Lung Cancer Clinical Trial

Official title:

A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03713099
• Other study ID #: NEU_2018_01
• Status: Withdrawn
• Phase: N/A
• Start date: July 31, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2020
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Adult patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung less than 2cm will undergo transbronchial microwave ablation performed by an interventional pulmonologist or thoracic surgeon using cone beam CT imaging for probe guidance and confirmation on ablation outcome. All treated patients will be followed for one year following the ablation procedure for efficacy and safety.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed Informed Consent

2. Patients greater or equal to 18 years of age

3. Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG])

4. Willing to fulfill all follow-up visit requirements

5. Medically inoperable and operable secondary soft tissue lesion(s) of the lung

6. 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.

Exclusion Criteria:

1. Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related

2. Pregnant or breastfeeding

3. Physical or psychological condition that would impair study participation

4. Patients with uncorrectable coagulopathy at the time of screening

5. Patient with implantable devices, including pacemakers or other electronic implants

6. Prior pneumonectomy or bronchiectasis

7. Severe neuromuscular disease

8. Patient count less than or equal to 50,000/mm cubed

9. ASA (American Society of Anesthesiologists) score of greater than or equal to 4

10. Inability to tolerate anesthesia

11. Expected survival less than 6 months

12. Clinically significant hypertension

13. 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)

14. Endobronchial soft tissue lesions proximal to the segmental airways

15. Imaging findings of active pulmonary infection

16. The patient was judged unsuitable for study participation by the Investigator for any other reason.

Related Conditions & MeSH terms

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

Intervention

Device:
• Microwave ablation
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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	City of Hope	Duarte	California
United States	New York Presbyterian-Weill Cornell Medicine	New York	New York
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EORTC QLQ-C30	The EORTC (European Organization for Research and Treatment of Cancer) QLQ-C30 is a quality of life questionnaire with 30 questions aimed specifically for cancer patients. Patients will complete this questionnaire at each study visit.	1 year post-ablation
Other	EORTC QLQ-LC13	The EORTC (European Organization for Research and Treatment of Cancer) QLQ-C30 is a quality of life questionnaire with 13 questions aimed specifically for lung cancer patients. The questionnaire asks patients to rate their responses on a scale from 1-4 (1 being "not at all" and 4 being "very much"). Patients will complete this questionnaire at each study visit.	1 year post-ablation
Other	Numeric Pain Scale	The Numeric Pain Scale is a questionnaire where the patient reports their pain on a scale from 0-10 (where 0 is 'no pain' and 10 is 'maximum pain). Patients will complete this questionnaire at each study visit through 30 days post-ablation.	30 days post-ablation
Primary	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)
Primary	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)
Primary	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	Adverse Events	Any AEs attributable to the ablation procedure, including all device-related, procedure-related, and SAEs, evaluated from the start of the ablation procedure throughout the entirety of the study (i.e. through 1 year post-ablation).	1 year post-ablation
Secondary	Primary Efficacy Rate	The Primary Efficacy Rate is the percentage of target lesions successfully eradicated following the first ablation procedure, as assessed using CT imaging by the treating physician on the day of ablation.	Day of ablation (day 0)
Secondary	Secondary Efficacy Rate	The Secondary Efficacy Rate is defined as the percentage of soft tissue lesions that have undergone successful repeat ablations following identification of local soft tissue lesions progression, as assessed using CT imaging by the treating physician throughout the entirety of the study (i.e. 1 year post-ablation).	1 year post-ablation
Secondary	Target Lesion Recurrence	Target Lesion Recurrence is defined as the reappearance of the lesion(s) at the treated site, as assessed using CT imaging by the treating physician throughout the entirety of the study (i.e. through 1 year post-ablation).	1 year post-ablation
Secondary	Length of Hospital Stay	The Length of Hospital Stay is defined as the length of time of hospitalization from the end of the ablation procedure to the time of discharge (up to 23 hours post-ablation).	Day of ablation (day 0)
Secondary	Hospital Readmission Rate	The Hospital Readmission Rate is defined as the percentage of patients who were readmitted to the hospital within 30 days of the ablation procedure.	30 days post-ablation