CellFX ® Percutaneous Electrode (PE) Treatment of Symptomatic Benign Thyroid Nodules

NCT06117085 | Completed

• 1 other identifier: NP-TF-024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical feasibility study is to evaluate initial clinical safety and device performance of the CellFX Percutaneous Electrode (PE) System for the treatment of symptomatic benign thyroid nodules.

Conditions

Thyroid Nodule (Benign)

Outcome Measures

Primary Outcomes (2)

• Number of Participants with serious adverse device effects

  The primary safety endpoint will be assessed by the incidence of serious adverse device effects

  1 month, 3 months, 6 months and 12 months post-CellFX PE procedure

• Number of Participants with Acute nodular volume loss

  Acute procedural success defined as a ≥ 50% nodule volume loss by ultrasonography and without serious adverse device effects within 6-months of the procedure

  6 months post-CellFX PE procedure

Study Arms (1)

Percutaneous Treatment Arm

EXPERIMENTAL

CellFX Percutaneous Treatment under ultrasound guidance using nanosecond Pulse Field Ablation (nsPFA)

Device: CellFX® Percutaneous Electrode (PE) System

Interventions

CellFX® Percutaneous Electrode (PE) System DEVICE

Percutaneous treatment with CellFX® Percutaneous Electrode using nanosecond pulse field ablation (nsPFA) technology

Percutaneous Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be at least 18 or no older than 80 years of age
• Participant gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
• Participant must comply with study procedures including all follow-up visits diagnosis of thyroid nodule confirmed by ultrasonography ≤Grade 3 (2017 ACR TI-RADS and fine needle aspiration biopsy FNA (Bethesda category II ) with no macro-calcifications in target nodule within 30 days of enrollment
• Participant has single nodule ≤ 6.0 cm in greatest dimension.
• Participant may have abnormal thyroid function, such as suppressed thyrotropin (TSH) levels, at the screening visit
• Participant has no abnormal cervical lymph nodes during screening visit examination
• Participant has thyroid nodule causing appearance, pressure or swallowing symptoms
• Participant has absence of abnormal vocal cord mobility by ultrasound evaluation

You may not qualify if:

• Participant has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter defibrillator)
• Participant has an active systemic infection on the day of the CellFX PE procedure with either fever, leukocytosis or requiring intravenous antibiotics or history of head and neck, pulmonary or systemic infection in the last 2 weeks prior to CellFX PE procedure
• Participant is known to be immune compromised
• Participant is a member of a vulnerable population including individuals employed by the Sponsor, clinic site, or entity associated with the conduct of the study
• Participant had previous neck irradiation
• Participant has history of familial thyroid cancer in more than two first-degree relatives
• Participants currently suffering from hematological diseases or bleeding tendency, or patients currently requiring continuous administration of antiplatelet and anticoagulant drugs
• Ultrasonographic evidence of calcifications, irregular margins or sonographic features that are suspicious for malignancy
• Nodule likely to be in contact with the recurrent laryngeal nerve on ultrasound evaluation
• History of cardiac arrhythmia, uncontrolled hypertension, liver or kidney disease, or recent history of myocardial infarctions or structural heart disease as determined by the Investigator
• History of a coagulation mechanism disorder or bleeding tendency
• Abnormal contralateral vocal cord function
• Allergy or contraindication to assigned analgesia/anesthesia
• Females of childbearing potential who are nursing, pregnant, or planning to become pregnant during the study period
• Have any condition or situation which, in the Investigator's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the participant's participation in the study

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (1)

Ospedale del Mare | ASLNA1 Centro

Naples, Italy

Location

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Prof Stefano Spiezia, MD

  Chief of Endocrine and Ultrasound Guided Surgery, Operative Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 3, 2023
• Study Start: April 13, 2023
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)