Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion:

Description

Summary

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.

Official Title

Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy

Details

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).

Keywords

Metastatic Lung Cancer Cryoablation Cryotherapy Cryosurgery Metastatic Lung Pleura Tumors Lung Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Ronald Regan UCLA Medical Center
    Los Angeles California 90095 United States
  • Mayo Clinic Rochester
    Rochester Minnesota 55905 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Galil Medical
ID
NCT01307501
Study Type
Interventional
Last Updated