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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Intraepithelial Neoplasia Grade 2; CIN2; Cervical Intraepithelial Neoplasia Grade 2 (CIN2)
• Intervention / Treatment: Device: Treatment with low-thermal argon plasma devitalization; Device: Sham treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Weiss, Prof. Dr.; Phone Number: +49 7071 29 82211; Email: martin.weiss@med.uni-tuebingen.de

Study Locations

• Germany
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • University Hospital Tuebingen, Department of Women's Health
      • Contact: Martin Weiss, Prof. Dr.; Phone Number: +49 7071 29 82211; Email: martin.-weiss@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham; Sham treatment	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.
Experimental: LtAPD; Treatment with low-thermal argon plasma devitalization	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV remission rate	Percentage of patients with HPV remission, assessed by validated HPV testing and p16 immunohistochemistry	at 6 months
Cytological remission of CIN	Percentage of patients with cytological remission, assessed by Papanicolaou (PAP) smear according to the Bethesda classification system	at 6 months
Quality of life, comfort/ discomfort of the treatment procedure and sexual activity	Change from baseline in quality of life and sexual health at baseline and 6 months, assessed by the Freiburg Index of Patient Satisfaction (FIPS) and the Sexual Activity Questionnaire (SAQ)	at baseline, intervention, 6 months
Correlation of electrosurgical unit (ESU) and video data with CIN remission and applied argon plasma	assessed by correlation of ESU and video data with CIN remission and applied argon plasma	at 6 months

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Felix Neis, PD Dr., University Hospital Tuebingen, Department of Women's Health, Tübingen

Study record dates

Study Major Dates

• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: CIN2; Cervical Intraepithelial Neoplasia Grade 2; Low-thermal argon plasma devitalization; LtAPD; Plasma application; Plasma treatment; Physical plasma; Physical plasma treatment
• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: MolGyn_BMBF_CINPLASTA; DE-26-0000510067 (Other Identifier: German ID of Federal Institute for Drugs and Medical Devices)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No