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

NCT03603652 | Terminated Results DMC FDA Device

• 1 other identifier: NEU_2017_06
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Lung Lesions; Soft Tissue- Lung

Outcome Measures

Primary Outcomes (7)

• 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.

  Immediately post-ablation (day 0)

• Number of Patients Whose Ablation Resulted in Technique Efficacy

  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.

  30 days post-ablation

• User Experience Survey (Part I)

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

  Immediately post-ablation

• User Experience Survey (Part II)

  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.

  Immediately post-ablation

• User Experience Survey (Part III)

  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.

  Immediately post-ablation

• User Experience Survey (Part IV)

  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.

  Immediately post-ablation

• User Experience Survey (Part V)

  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.

  Immediately post-ablation

Secondary Outcomes (2)

• Number of Patients Who Experienced Target Lesion Recurrence

  measured at 6 months and 1 year post-ablation

• Number of Patients Who Were Readmitted to the Hospital

  Within 30 days post-ablation

Study Arms (1)

Microwave Ablation

EXPERIMENTAL

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

Device: Microwave Ablation

Interventions

Microwave Ablation DEVICE

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.

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 ≥ 18 years old.
• Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.
• Willing to fulfill all follow-up visit requirements.
• 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)
• 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)
• Radiographic resolution of pneumonia

You may not qualify if:

• Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related.
• Pregnant or breastfeeding.
• Physical or psychological condition that would impair study participation.
• Patients with uncorrectable coagulography at time of screening.
• Patient with implantable devices, including pacemakers or other electronic implants.
• Prior pneumonectomy or bronchiectasis.
• Severe neuromuscular disease.
• Platelet count ≤ 50,000/mm3.
• ASA (American Society of Anesthesiologists) score of ≥ 4.
• Inability to tolerate anesthesia.
• Expected survival less than 6 months.
• Clinically significant hypertension.
• Chronic ventilator support, which uses bi-level positive airway pressure (PAP).
• Endobronchial soft tissue lesions proximal to the segmental airways

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

Results Point of Contact

• Title: Erin Meyers
• Organization: ETHICON

eprifog1@its.jnj.com

937-681-0322

Study Officials

• Thomas Gildea, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Michael Pritchett, MD

  FirstHealth Moore Regional Hospital

  PRINCIPAL INVESTIGATOR

• Janani Reisenauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Bradley Pua, MD

  Cornell

  PRINCIPAL INVESTIGATOR

• Jae Kim, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: May 16, 2018
• First Posted: July 27, 2018
• Study Start: June 29, 2018
• Primary Completion: December 21, 2018
• Study Completion: October 24, 2019
• Last Updated: December 21, 2020
• Results First Posted: December 21, 2020

Record last verified: 2020-12

Locations

US (5)