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

NCT07730645 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-08-03

No results posted yet for this study

Summary

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).

Conditions

  • Cervical Intraepithelial Neoplasia Grade 2 (CIN2)
  • Cervical Intraepithelial Neoplasia Grade 2
  • CIN2

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.

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Felix Neis, PD Dr. · University Hospital Tuebingen, Department of Women's Health, Tübingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-17
Primary Completion
2029-03-31
Completion
2029-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07730645 on ClinicalTrials.gov