Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space("ICE PLS")

CSA Medical

Status and phase: Terminated; Phase 4

Conditions: Pleural Neoplasms; Cancer

Treatments: Device: CryoSpray Ablation (TM) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00747916

17-00027

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, efficacy, and side effects of the CryoSpray Ablation(TM) System (CSA(TM) System) to treat neoplastic lesions on the parietal pleural surface.

Full description

The proposed study is a pilot study consisting of an estimated 10 subjects with biopsy-proven metastatic cancer in the parietal pleural surface treated with CryoSpray at dye marked metastatic foci.

Initial treatment dosimetry will be up to 3 cycles of 10-40 second sprays. If necessary, dosimetry changes may occur after 3 subjects are treated and observed. It is unknown if dosimetry will need to be increased to enhance effectiveness. The PI may increase dosimetry by 1 cycle after each subject is treated and observed as a conservative approach to efficacy determination. If disease exists bilaterally, only one side will be sprayed.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age
• Deemed a candidate for cryotherapy based on physician physical or medical history review
• Deemed operable based on institutional criteria
• Able to sign informed consent
• Documented lung or other visceral cancer with pleural involvement.
• WBC > 4,000/mm3, platelets >100,000mm3
• Physically well enough to undergo moderate sedation and pleuroscopy
• Female patients must be HCG negative
• There should be direct evidence of disease progression despite treatment in previously treated patients

Exclusion criteria

• Pregnant or nursing
• Planning to sire a child while enrolled in the study
• Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
• Refusal or inability to give consent.
• Concurrent chemotherapy.
• Medical contraindication or potential problem that would preclude study participation
• Concurrent participation in other experimental studies
• Uncontrolled coagulopathy or bleeding diathesis
• Serious medical illness, including:
• Uncontrolled congestive heart failure
• Uncontrolled angina
• Myocardial infarction
• Cerebrovascular accident within 6 months prior to study entry

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

CryoSpray Ablation (TM) System

Experimental group

Description:

subjects will receive cryotherapy using the CryoSpray Ablation (TM) System DOSE: up to 3 cycles of 10-40 second sprays

Treatment:

Device: CryoSpray Ablation (TM) System