Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117085
Status:
RECRUITING
Last Update Posted:
2023-11-03
First Post:
2023-10-26
Brief Title:
CellFX Percutaneous Electrode PE Treatment of Benign Thyroid Nodules
Sponsor:
Pulse Biosciences Inc
Organization:
Pulse Biosciences Inc
Study Overview
Official Title:
First Clinical Feasibility Study Using the CellFX Percutaneous Electrode PE System for the Treatment of Benign Thyroid Nodules
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None