eClinical Technology and Industry News

Pulse Biosciences Announces Publication of First-In-Human Data for Treatment of Benign Thyroid Nodules in the Journal Thyroid

First-in-Human Clinical Feasibility Study Demonstrates Effectiveness of Ablation of Benign Thyroid Nodules Using Nanosecond Pulsed Field Ablation

Excerpt from the Press Release:

HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology, today announced a new publication in the Journal Thyroid. The First-in-Human Clinical feasibility study demonstrates the effectiveness of ablation of benign thyroid nodules using nsPFA energy.

The study was designed to assess the ability of nsPFA energy to provide a safe and effective option for the treatment of symptomatic benign thyroid nodules with minimal side effects. The study was conducted by Professor Stefano Spiezia as a single-arm First-In-Human feasibility study at the Ospedale del Mare center in Naples, Italy. The CellFX nsPFA Percutaneous Electrode System was used under ultrasound guidance to ablate benign thyroid nodules, as either isolated ablations to assess tissue response (Cohorts 1 & 2) or for full treatment of thyroid nodules with therapeutic intent (Cohort 3). Results showed no intranodular fibrosis or scarring on follow-up ultrasounds and fully treated nodules (Cohort 3) had up to 93% reduction in size at 1 year on ultrasound assessment (average 86% reduction), with symptom relief and >48% reduction as early as 2 weeks.

“We are very proud to have this data published in a leading scientific journal in the field, the renowned Journal Thyroid. The results of this study are extremely compelling and demonstrate nsPFA’s ability to offer advantages in treating benign thyroid nodules compared to other methods such as thyroidectomy or thermal ablation.

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