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Not yet recruiting NCT07730645

Evaluation of Low-thermal Argon Plasma Devitalization for the Treatment of CIN 2 Versus Standard of Active Surveillance

No phase Interventional Cervical Intraepithelial Neoplasia Grade 2 (CIN2) Cervical Intraepithelial Neoplasia Grade 2 CIN2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treatment with low-thermal argon plasma devitalization, Sham treatment.
Who it may be relevant to
Registry conditions: Cervical Intraepithelial Neoplasia Grade 2 (CIN2), Cervical Intraepithelial Neoplasia Grade 2, CIN2. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of Low-thermal Argon Plasma Devitalization (LtAPD) for the Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade 2 Versus Standard of Active Surveillance

Overview

The study aims to show that treatment with LtAPD works better than a sham treatment or simply monitoring the condition closely without active treatment ("active surveillance"), in achieving complete healing of a tissue abnormality on the cervix called CIN 2, after 6 months. This will be confirmed by examining tissue samples under a microscope (histopathological examination).

Detailed description

Participation in the study lasts 6 months. Eligible participants are randomly assigned to one of two groups: participants receiving LtAPD treatment (treatment group) or participants receiving a sham procedure, in which LtAPD treatment is simulated but not actually applied (control group). All participants continue to be managed according to the current standard of care, active surveillance with regular monitoring, throughout the study. Participants remain blinded to their treatment assignment. The study includes four visits.

Interventions

  • Device Treatment with low-thermal argon plasma devitalization
    Single session of LtAPD treatment applied to the CIN2 lesion under colposcopic guidance; outpatient, no anesthesia required.
  • Device Sham treatment
    Single session of sham treatment (no argon gas delivery and plasma ignition; acoustic signal to maintain blinding) followed by active surveillance according to current clinical guidelines.

Primary outcome measures

  • Histopathological remission of CIN 2 [Time frame: at 6 months]
Secondary outcome measures (4)
  • HPV remission rate [Time frame: at 6 months]
  • Cytological remission of CIN [Time frame: at 6 months]
  • Quality of life, comfort/ discomfort of the treatment procedure and sexual activity [Time frame: at baseline, intervention, 6 months]
  • Correlation of electrosurgical unit (ESU) and video data with CIN remission and applied argon plasma [Time frame: at 6 months]

Eligibility criteria

Inclusion criteria

  • Female sex
  • Age 18 - 40 years at the time of signing the informed consent
  • Histologically confirmed CIN 2
  • Full visibility of the entire transformation zone (Type 1 or Type 2) and entire lesion in colposcopy
  • Ability to understand the nature of the clinical investigation and voluntarily signs the informed consent document prior to any study-related procedures

Exclusion criteria

  • Histologically confirmed CIN other than CIN 2, or indication of (micro-) invasive cervical disease
  • CIN lesions extending to the vaginal vault or suspicion of endocervical disease
  • Current pregnancy or planned pregnancy within the next 6 months
  • Presence of severe local inflammation or active infection
  • Presence of a severe cardiovascular, neurological, psychiatric, endocrine, or hematological disease, immunocompromised condition or malignant tumor of any origin, as judged by the investigator
  • Participation in an interfering clinical study, as judged by the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University Hospital Tuebingen, Department of Women's Health — Tübingen

Identifiers

NCT: NCT07730645 · MolGyn_BMBF_CINPLASTA · 01KG2503 · DE-26-0000510067

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗