NCT03218436
Completed
Not Applicable
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia
University Hospital Tuebingen1 site in 1 country63 target enrollmentStarted: September 1, 2017Last updated:
ConditionsCervical Intraepithelial Neoplasia
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Pathological remission of cervical intraepithelial neoplasia
Overview
Brief Summary
Cervical intraepithelial neoplasia will be treated with physical low temperature plasma in the plasma cohort compared to watchful waiting in the control cohort.
Primary endpoint after 3-6 months: Pathological remission.
Secondary endpoint: HPV remission.
Detailed Description
The study was completed with Less recruitment as it was planned due to overwhelming study success. The study was published in August 2023. A link has been added to the Reference section.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Histologically confirmed CIN III
- •Not fully visible transformation zone
- •An indication of invasive disease
- •Expected lack of compliance of the patient or incapacity of the patient to understand the meaning and purpose of the clinical trial
- •Severe cardio-vascular disease
- •Lack of patient consent
Outcomes
Primary Outcomes
Pathological remission of cervical intraepithelial neoplasia
Time Frame: 3-6 months
Biopsy, Histopathological examination
Secondary Outcomes
- Human papilloma virus remission rate(3-6 months)
- Comfort / Dyscomfort during intervention(Immediately, 2 week, 3-6 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous PolyposisAdenomatous Polyposis ColiFamilial Adenomatous PolyposisDuodenal AdenomaNCT06435533Universitätsklinikum Hamburg-Eppendorf10
Completed
Not Applicable
The use of cold atmospheric plasma for therapeutical use in modern wound careI87.2L97I70.24I87.21Venous insufficiency (chronic)(peripheral)Ulcer of lower limb, not elsewhere classifiedDRKS00025767Klinik und Poliklinik für Dermatologie und Allergologie der Universität München11
Completed
Phase 2
The therapeutic use of cold atmospheric plasma for treatment of light acne papulopustulosaL70.0Acne vulgarisDRKS00032416Dermatologie am Luisenplatz40
Active, not recruiting
Not Applicable
Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer HealingVenous Leg UlcerNCT05894096Clinica Universidad de Navarra, Universidad de Navarra68
Recruiting
Not Applicable
Using a Cold Atmospheric Plasma Device to Treat Skin DisordersActinic KeratosisAcne/RosaceaVerruca PlanaTineaMolluscum ContagiosumBowen's DiseaseWartsNCT02759900The Skin Center Dermatology Group100