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

NCT07730645 | Not Yet Recruiting DMC

• 2 other identifiers: MolGyn_BMBF_CINPLASTADE-26-0000510067
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CIN2; Cervical Intraepithelial Neoplasia Grade 2; Low-thermal argon plasma devitalization; LtAPD; Plasma application; Plasma treatment; Physical plasma; Physical plasma treatment

Outcome Measures

Primary Outcomes (1)

• Histopathological remission of CIN 2

  Percentage of patients with histopathologically confirmed remission of CIN 2 (absence of CIN 2 or higher grade lesion), assessed by cervical biopsy/histopathological evaluation

  at 6 months

Secondary Outcomes (4)

• HPV remission rate

  at 6 months

• Cytological remission of CIN

  at 6 months

• Quality of life, comfort/ discomfort of the treatment procedure and sexual activity

  at baseline, intervention, 6 months

• Correlation of electrosurgical unit (ESU) and video data with CIN remission and applied argon plasma

  at 6 months

Study Arms (2)

LtAPD

EXPERIMENTAL

Treatment with low-thermal argon plasma devitalization

Device: Treatment with low-thermal argon plasma devitalization

Sham

SHAM COMPARATOR

Sham treatment

Device: Sham treatment

Interventions

Treatment with low-thermal argon plasma devitalization DEVICE

Single session of LtAPD treatment applied to the CIN2 lesion under colposcopic guidance; outpatient, no anesthesia required.

LtAPD

Sham treatment DEVICE

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.

Sham

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female reproductive organs required
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen, Department of Women's Health

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Felix Neis, PD Dr.

  University Hospital Tuebingen, Department of Women's Health, Tübingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Weiss, Prof. Dr.

CONTACT

+49 7071 29 82211; martin.weiss@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)