NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung

A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Medically Inoperable Primary Soft Tissue Lesions of the Lung: An Initial Experience

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03603652

Enrollment

Registered

2018-07-27

Start date

2018-06-29

Completion date

2019-10-24

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Lung Lesions; Soft Tissue- Lung

Brief summary

Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety.

Detailed description

Patients with medically inoperable primary soft tissue lesion of the lung (lesions less than or equal to 2cm and located in the outer two-thirds of the lung and not closer than 1cm to the pleura) will have transbronchial microwave ablation performed using CT imaging. All ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety with specific follow-up visits at 30 days, 6 months, and 12 months post-ablation. A user experience questionnaire is completed by the treating physician to better understand the ease of the procedure.

Interventions

DEVICEMicrowave Ablation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Signed informed consent. 2. Patients ≥ 18 years old. 3. Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification. 4. Willing to fulfill all follow-up visit requirements. 5. Medically inoperable primary soft tissue lesion of the lung or patient election not to have surgery. (Medically inoperable is defined per the following indicators: post op predictive FEV1 (forced expiratory volume in 1 second) \< 40%; DLCO (diffusing capacity of the lung for carbon monoxide) \< 40%; hypoxemia or hypercapnia diabetes with end-organ damage; or severe cerebral, cardiovascular, peripheral vascular disease, or chronic heart disease) 6. One soft tissue lesion ≤ 2 cm in the outer two thirds of the lung and not closer than 1 cm to the pleura. (Outer two thirds of the lung is defined as peripheral beyond the segmental airway, past the segmental bronchi, such that proximal endobronchial soft tissue lesions are avoided; soft tissue lesions should not be contiguous with the pleura) 7. Radiographic resolution of pneumonia

Exclusion criteria

1. Scheduled concurrent procedure for the target soft tissue lesion 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 coagulography at time of screening. 5. Patient with implantable devices, including pacemakers or other electronic implants. 6. Prior pneumonectomy or bronchiectasis. 7. Severe neuromuscular disease. 8. Platelet count ≤ 50,000/mm3. 9. ASA (American Society of Anesthesiologists) score of ≥ 4. 10. Inability to tolerate anesthesia. 11. Expected survival less than 6 months. 12. Clinically significant hypertension. 13. Chronic ventilator support, which uses bi-level positive airway pressure (PAP). 14. Endobronchial soft tissue lesions proximal to the segmental airways

Design outcomes

Primary

Measure	Time frame	Description
User Experience Survey (Part V)	Immediately post-ablation	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many times the probe had to be repositioned to complete the ablation procedure.
User Experience Survey (Part III)	Immediately post-ablation	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many cone-beam CT (CBCT) scans were taken to place the probe such that it was ready for ablation.
User Experience Survey (Part IV)	Immediately post-ablation	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the distance of the tip of the probe to the center of the soft-tissue lesion (in mm) just before the ablation procedure was initiated.
Number of Patients Whose Ablation Resulted in Technical Success	Immediately post-ablation (day 0)	Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.
Number of Patients Whose Ablation Resulted in Technique Efficacy	30 days post-ablation	Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT imaging, 30 days (+/- 7 days) after the first ablation procedure.
User Experience Survey (Part I)	Immediately post-ablation	A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.
User Experience Survey (Part II)	Immediately post-ablation	A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the time it took to place the probe in a position that was ready for ablation.

Secondary

Measure	Time frame	Description
Number of Patients Who Were Readmitted to the Hospital	Within 30 days post-ablation	Any readmission to the hospital within 30 days of the ablation procedure.
Number of Patients Who Experienced Target Lesion Recurrence	measured at 6 months and 1 year post-ablation	Analyzed at 6 months and 1 year post-ablation via CT imaging

Countries

United States

Participant flow

Participants by arm

Arm	Count
Microwave Ablation Each participant underwent microwave ablation to the original soft tissue lesion in the lung at single visit. The treating physician determined the ablation time and power used on a case-by-case basis.	10
Total	10

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	2

Baseline characteristics

Characteristic	Microwave Ablation
Age, Continuous	69.3 Years STANDARD_DEVIATION 7.689
BMI	26.8 kg/m^2 STANDARD_DEVIATION 4.469
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	9 Participants
Radiation History No, radiation history	9 Participants
Radiation History Yes, radiation history	1 Participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	4 Participants
Smoking Status Current Smoker	3 Participants
Smoking Status Former Smoker	6 Participants
Smoking Status Non-Smoker	1 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	2 / 10
other Total, other adverse events	9 / 10
serious Total, serious adverse events	3 / 10

Outcome results

Primary

Number of Patients Whose Ablation Resulted in Technical Success

Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.

Time frame: Immediately post-ablation (day 0)

Population: All treated patients.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Microwave Ablation	Number of Patients Whose Ablation Resulted in Technical Success	10	10 Participants

Primary

Number of Patients Whose Ablation Resulted in Technique Efficacy

Time frame: 30 days post-ablation

Population: Patients analyzed at 30 days post-ablation.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Microwave Ablation	Number of Patients Whose Ablation Resulted in Technique Efficacy	9 Participants

Primary

User Experience Survey (Part I)

A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.