Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03713099
Other study ID # NEU_2018_01
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Active, not recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05898594 - Lung Cancer Screening in High-risk Black Women N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT06052449 - Assessing Social Determinants of Health to Increase Cancer Screening N/A
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk