Safety and Efficacy of Cryoablation for Metastatic Lung Tumors

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCryoablation

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 19, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Boston Scientific Corporation

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Not applicable
Sponsor: Boston Scientific Corporation
Interventions being studied: Device: Cryoablation

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Participant must be at least 18 years old.
Participant has signed a written informed consent.
Participant presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy or confirmed on imaging with known primary disease.
Participant 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 (by CT/MRI) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures.
Eastern Cooperative Oncology Group (ECOG) score of 0-2.
Karnofsky Performance Scale (KPS) score ≥60.
Platelet count \>50,000/cubed millimeters (mm\^3) within 60 days prior to study treatment.
International normalized ratio (INR) less than 1.5 within 60 days prior to study treatment.
Participant has a life expectancy of \>3 months.
Participant is clinically suitable for cryoablation procedure.

Reasons someone may not be able to joinExclusion criteria

Participant's primary cancer is lung cancer.
Participant is unable to lie flat or has respiratory distress at rest.
Participant has uncontrolled coagulopathy or bleeding disorders.
Participant 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.
Participant has a history of an allergic reaction to iodine injections or to shellfish.
Participant has evidence of active systemic, pulmonary, or pericardial infection.
Participant has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
Participant is currently participating in other experimental studies that could affect the primary endpoint.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Ronald Regan UCLA Medical CenterLos Angeles, California
Karmanos Cancer InstituteDetroit, Michigan
Mayo Clinic RochesterRochester, Minnesota
Institut Gustave RoussyVillejuif, Cedex

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 19, 2021. Always confirm current availability with the study team.

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