Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma (ICE-SECRET)

IceCure Medical

Status: Active, not recruiting

Conditions: Renal Cell Carcinoma

Treatments: Device: PROSENSE™

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02399124

ICMRC-01

Details and patient eligibility

About

This experiment is designed for post marketing data collection of a cryosurgical system [PROSENSE™ of IceCure Medical], for the treatment of renal cell carcinoma (RCC).

Full description

A post marketing data collection of a cryosurgical system [PROSENSE™] of IceCure Medical], for the treatment of renal cell carcinoma (RCC).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is above 18 years old.
2. The patient has enhanced solid mass of renal origin located in the kidney or elsewhere proved by imaging.
3. Patient's mass size is up to 5 cm at its largest dimension.
4. Patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure.
5. The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.

Exclusion criteria

1. Patients with permanent coagulation disorders or severe medical instability or active infection.
2. Patients with any terminal illness.
3. Patient participating in other trials using drugs or devices.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

single arm, open label, treatment

Other group

Description:

single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance

Treatment:

Device: PROSENSE™