Snipe First in Human Study
Research type
Research Study
Full title
A PROSPECTIVE, OPEN LABEL, MULTI CENTER, SINGLE ARM, FIRST IN HUMAN STUDY TO ASSESS THE SAFETY AND INITIAL PERFORMANCE OF EAS1 SYSTEM FOR IRREVERSIBLE ELECTROPORATION (IRE) ABLATION OF LUNG CANCER IN SUBJECTS ELIGIBLE FOR TUMOR RESECTION
IRAS ID
342510
Contact name
Pallav Shah
Contact email
Sponsor organisation
Snipe Medical Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 15 days
Research summary
Snipe Medical has developed the Eel Ablation System (EAS1 System) which is intended to ablate malignant lung tumors in patients who are scheduled to undergo a lung tumor resection. This study is designed in order to assess the device's safety in the intended population, and to provide initial data on device performance.
This study is a non-randomized, open label, single arm, multi center, First in Human study.
Up to 15 participants will be enrolled at investigational sites in Israel and Europe.
Potential participants will sign an informed consent form prior to any study related procedures are performed, and after duly receiving explanation about the study and related procedures. Eligibility will be evaluated prior to the procedure (Days -14 – 0). Eligible subjects, who meet the inclusion and exclusion criteria, and who have undergone tumor biopsy for malignancy verification, will undergo the ablation procedure with the EAS1 (Day 0). During the procedure, a cone-beam CT will be used to confirm the device needle is in lesion prior to ablation. Preparation for the procedure, as well as discharge and follow up, will be performed according to the common practice for lung ablations at the medical center. Each subject will undergo the standard of care tumor resection up to 15 days following the ablation. Resection surgery preparation, recovery and follow up will be performed according to the standard of care at the medical center. Participation in this study is expected to take approximately 2 months in total for each patient and includes three follow up visits - two phone follow up calls 48 hours and 14 days post procedure and one in hospital visit 30 days post procedure.
The Sponsor - Snipe Medical Ltd. is funding the study.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
24/WM/0173
Date of REC Opinion
24 Sep 2024
REC opinion
Further Information Favourable Opinion