Thyroid Nodule (Benign)NCT06117085
CellFX ® Percutaneous Electrode (PE) Treatment of Symptomatic Benign Thyroid Nodules
A study testing CellFX® Percutaneous Electrode (PE) System in people with Thyroid Nodule (Benign), run by Pulse Biosciences, Inc. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Nodule (Benign)
- What is being tested?
- CellFX® Percutaneous Electrode (PE) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2023to 18 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Use of any other investigational drug, therapy, or device within 30 days prior to enrollment or concurrent participation in another research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Clinical Feasibility Study Using the CellFX® Percutaneous Electrode (PE) System for the Treatment of Symptomatic Benign Thyroid Nodules
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.
Read the detailed description
Cohort 1: (CellFX PE Procedure and Surgery) The first five enrolled subjects will be patients with planned thyroidectomy. The site investigator will perform the CellFX procedure followed by an ultrasound evaluation. The site investigator will then perform a partial or total thyroidectomy. Tissue samples from the CellFX targeted treated areas will be sent to the pathology lab for gross and histological evaluation. The participant will exit the study on the same day of surgery.
Cohort 2: (CellFX PE Procedure with 12 months follow-up) When Cohort 1 is completed, up to 25 subjects will undergo a CellFX treatment using a percutaneous approach under ultrasound guidance. After CellFX treatment, all subjects will be followed weekly until 1 month, 3 months, 6 months and 12 months post-CellFX PE procedure.
- Conditions
- Thyroid Nodule (Benign)
- Being tested
- CellFX® Percutaneous Electrode (PE) System
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellFX® Percutaneous Electrode (PE) SystemDevice
Percutaneous treatment with CellFX® Percutaneous Electrode using nanosecond pulse field ablation (nsPFA) technology
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Treatment Arm | Experimental | CellFX Percutaneous Treatment under ultrasound guidance using nanosecond Pulse Field Ablation (nsPFA) Receives: Device: CellFX® Percutaneous Electrode (PE) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with serious adverse device effects
The primary safety endpoint will be assessed by the incidence of serious adverse device effects
Measured: 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
Measured: 6 months post-CellFX PE procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start13 Apr 2023
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Nodule (Benign)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof Stefano Spiezia, MD, Principal investigator, Chief of Endocrine and Ultrasound Guided Surgery, Operative Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117085
- Sponsor's protocol ID
- NP-TF-024
- Status last verified
- Nov 2024
- First submitted
- 26 Oct 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Clinical Feasibility Study Using the CellFX® Percutaneous Electrode (PE) System for the Treatment of Symptomatic Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT06117085
- Acronym / sponsor ID
- NP-TF-024
- Conditions
- Thyroid Nodule (Benign)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cohort 1: (CellFX PE Procedure and Surgery) The first five enrolled subjects will be patients with planned thyroidectomy. The site investigator will perform the CellFX procedure followed by an ultrasound evaluation. The site investigator will then perform a partial or total thyroidectomy. Tissue samples from the CellFX targeted treated areas will be sent to the pathology lab for gross and histological evaluation. The participant will exit the study on the same day of surgery.
Cohort 2: (CellFX PE Procedure with 12 months follow-up) When Cohort 1 is completed, up to 25 subjects will undergo a CellFX treatment using a percutaneous approach under ultrasound guidance. After CellFX treatment, all subjects will be followed weekly until 1 month, 3 months, 6 months and 12 months post-CellFX PE procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Treatment Arm | Experimental | Device: CellFX® Percutaneous Electrode (PE) SystemCellFX Percutaneous Treatment under ultrasound guidance using nanosecond Pulse Field Ablation (nsPFA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CellFX® Percutaneous Electrode (PE) SystemPercutaneous treatment with CellFX® Percutaneous Electrode using nanosecond pulse field ablation (nsPFA) technology | Device | Percutaneous Treatment Arm |
Primary outcome
Number of Participants with serious adverse device effects
Time frame: 1 month, 3 months, 6 months and 12 months post-CellFX PE procedure
The primary safety endpoint will be assessed by the incidence of serious adverse device effects
Number of Participants with Acute nodular volume loss
Time frame: 6 months post-CellFX PE procedure
Acute procedural success defined as a ≥ 50% nodule volume loss by ultrasonography and without serious adverse device effects within 6-months of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Stefano Spiezia, MD principal investigator
Chief of Endocrine and Ultrasound Guided Surgery, Operative Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellFX® Percutaneous Electrode (PE) System in people with Thyroid Nodule (Benign), run by Pulse Biosciences, Inc. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with serious adverse device effects (time frame: 1 month, 3 months, 6 months and 12 months post-CellFX PE procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.