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Safety and Efficacy of Cryoablation for Metastatic Lung Tumors (ECLIPSE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307501
First Posted: March 3, 2011
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galil Medical
March 1, 2011
March 3, 2011
July 14, 2017
August 2011
July 2018   (Final data collection date for primary outcome measure)
  • Local tumor control as measured by imaging [ Time Frame: 60 months ]

    Measure definitions (all measured by number of tumors):

    • Local Control (absence of local failure)
    • Complete Response(tumor disappearance (scar) or less than 25% of original size)
    • Partial Response (greater than 30% decrease in the sum of the largest diameter of all targeted tumors)
    • Stable Disease (less than 30% decrease in the sum of the largest diameter of all targeted tumors)
    • Local Failure (greater than 20% increase in the sum of the largest diameter of all targeted tumors)
  • Metastatic disease spread as measured by imaging [ Time Frame: 60 months ]

    Measure definition (measured by number of patients):

    -Distant Failure (the appearance of distant cancer deposits consistent with metastatic spread of cancer outside the intended treatment area)

Local tumor control as measured by imaging [ Time Frame: 12 months ]

Measure definitions:

  • Local Control (absence of local failure)
  • Complete Response(tumor disappearance (scar) or less than 25% of original size)
  • Partial Response (greater than 30% decrease in the sum of the largest diameter of all targeted tumors)
  • Stable Disease (less than 30% decrease in the sum of the largest diameter of all targeted tumors)
  • Local Failure (greater than 20% increase in the sum of the largest diameter of all targeted tumors)
  • Distant Failure (the appearance of distant cancer deposits consistent with metastatic spread of cancer outside the intended treatment area)
Complete list of historical versions of study NCT01307501 on ClinicalTrials.gov Archive Site
  • Overall disease specific survival [ Time Frame: 60 months ]
    Survival of these patients will be measured by time in days from cryoablation procedure to death.
  • Time to disease recurrence or progression [ Time Frame: 60 months ]
    Disease recurrence or progression will be determined locally by evidence of an increase in tumor size and/or contrast enhancement.
  • Changes in physical function and quality of life over time [ Time Frame: 60 months ]
    Physical performance (Eastern Cooperative Oncology Group and Karnofsky Performance Scale) and quality of life (Short Form-12) assessments will be made by examining the change in the baseline scores to those reported postoperatively.
  • Cryoablation technical success [ Time Frame: 60 months ]

    A technically successful treatment will be defined by an ablation volume encompassing the tumor with at least a 5 mm margin.

    Technical success will be calculated on a per tumor level as well as a patient level. To be considered a technical success on a patient level all tumors treated during the baseline procedure must meet the technical success criteria.

  • Safety assessment [ Time Frame: 30 days post-cryoablation ]
    The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Cryoablation for Metastatic Lung Tumors
Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy
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.

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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Intervention Model Description:
All participants received the same treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Lung Cancer
Device: Cryoablation
All patients will receive cryoablation of up to 5 metastatic lung tumors bilaterally.
Other Names:
  • Visual-ICE Cryoablation System
  • PresIce Cryoablation System
  • SeedNet Cryoablation System
  • IceRod Cryoablation Needles
  • IceRod PLUS Cryoablation Needles
  • IceSphere Cryoablation Needles
  • IceSeed Cryoablation Needles
  • IceEDGE 2.4 Cryoablation Needles
Cryoablation
Freezing of the tumor(s)
Intervention: Device: Cryoablation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
July 2018
July 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   United States
 
 
NCT01307501
CUC10-LNG06
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Plan to Share IPD: No
Galil Medical
Galil Medical
Not Provided
Study Chair: Hiran Fernando, MD Boston Medical Center
Galil Medical
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP