Clinical trial · Interventional
CellFX System for the Treatment of Cutaneous Non-Genital Warts
A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts
NCT04554394CI-TRIAL-00068277completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective, non-randomized, multicenter pivotal study is designed to evaluate the safety and effectiveness of the CellFX System in patients with cutaneous non-genital warts on all areas of the body, excluding the face.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Verruca | Verrucous Lesion | ALIAS | 0.90 |
| Warts | — | UNRESOLVED | — |
| Warts Hand | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CellFX Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CellFX Treated Wart
- description
- Treated wart with CellFX device intervention
- interventionNames
- Device: CellFX Device
- type
- NO_INTERVENTION
- label
- Non-treated Wart
- description
- Control wart for each enrolled subject without intervention
Primary outcomes (1)
- measure
- Percentage of Verrucae Cleared
- timeFrame
- 60-days post-last CellFX treatment
- description
- Percentage of Verrucae with Clearance (91-100% reduction)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must be at least 21 and not older than 80 years of age * Subjects must be able to read and speak English or Spanish * Subjects must sign a written informed consent to participate in the study, prior to any study related procedures * Subject must have a minimum of two cutaneous non-genital warts, each not exceeding 10 x 10mm * Subject is willing to undergo all study-mandated procedures * Subject agrees to refrain from using all other wart removal products or treatments (topical medication including over-the-counter medications) during the study period Exclusion Criteria: * Subject has an implantable electronic medical device. (pacemaker, implantable cardioverter defibrillator, etc.) * Subject has cochlear implants * Subject has an active systemic infection or history of an infection in the designated treatment area within 90 days of enrollment * Subject has a history of and/or current tinnitus * Subject is known to be immune-compromised * Subject is taking a blood thinning medication (Antiplatelet, Anticoagulation, Factor Xa Inhibitor, etc.) * Subject has Type 1 Diabetes and is insulin dependent * Subject has a known allergy to Lidocaine or Lidocaine-like products * Subject is a member of a vulnerable population including individuals employed by the Sponsor, clinic site, or entity associated with the conduct of the study * Subject has a comorbidity or condition which may reduce compliance with this protocol, including follow-up visits * Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device)
References
Publications (0)
Data not yet available
No reference posted for this study.