This trial is active, not recruiting.

Condition metastatic lung cancer
Treatment cryoablation
Phase phase 1
Sponsor Galil Medical
Start date August 2011
End date May 2014
Trial size 40 participants
Trial identifier NCT01307501, CUC10-LNG06


ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 cm in patients with pulmonary metastatic disease.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Freezing of the tumor(s)
cryoablation Visual-ICE Cryoablation System
All patients will receive cryoablation of up to 5 metastatic lung tumors bilaterally.

Primary Outcomes

Local tumor control as measured by imaging
time frame: 12 months

Secondary Outcomes

Overall disease specific survival
time frame: 60 months
Time to disease recurrence or progression
time frame: 60 months
Changes in physical function and quality of life over time
time frame: 60 months
Cryoablation technical success
time frame: 60 months
Safety assessment
time frame: 30 days post-cryoablation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient must be at least 18 years old. - Patient presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy or confirmed on imaging with known primary disease. - Patient has up to 3 local metastases unilaterally targeted by cryoablation. Maximum of 5 total pulmonary tumors bilaterally. - Targeted tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm. - The target tumor is determined to be in a location where cryoablation is technically achievable. - Eastern Cooperative Oncology Group (ECOG) score of 0-2. - Karnofsky Performance Scale score ≥60. - Platelet count >50,000/mm3. - INR less than 1.5. Exclusion Criteria: - Patient's primary cancer is lung cancer. - Patient has had chemotherapy with neutropenia to levels as confirmed by absolute neutrophil count (ANC) of less than 1000 that produce increase risk for the cryoablation procedure. - Patient has evidence of active systemic, pulmonary, or pericardial infection.

Additional Information

Official title Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy
Description ECLIPSE is a treatment, Phase 1 multicenter, prospective, single arm study with patients serving as their own control. This study is to enroll patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 cm. Patients will be followed to 5 years post their cryoablation procedure. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Galil Medical.