Cervical Intraepithelial Neoplasia Grade 2 (CIN2)CINPLASTANCT07730645
Evaluation of Low-thermal Argon Plasma Devitalization for the Treatment of CIN 2 Versus Standard of Active Surveillance
A study testing Treatment with low-thermal argon plasma devitalization in people with Cervical Intraepithelial Neoplasia Grade 2 (CIN2) and Cervical Intraepithelial Neoplasia Grade 2, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2 (CIN2), Cervical Intraepithelial Neoplasia Grade 2, CIN2
- What is being tested?
- Treatment with low-thermal argon plasma devitalization
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteGermany
- Study dates
- 24 Sep 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen, Department of Women's Health
Tübingen, Baden-Wurttemberg, 72076
Martin Weiss, Prof. Dr., +49 7071 29 82211, martin.-weiss@med.uni-tuebingen.de
About this study
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
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).
Read the 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.
- Conditions
- Cervical Intraepithelial Neoplasia Grade 2 (CIN2), Cervical Intraepithelial Neoplasia Grade 2, CIN2
- Being tested
- Treatment with low-thermal argon plasma devitalization, Sham treatment
- Keywords
- CIN2, Cervical Intraepithelial Neoplasia Grade 2, Low-thermal argon plasma devitalization, LtAPD, Plasma application, Plasma treatment, Physical plasma, Physical plasma treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with low-thermal argon plasma devitalizationDevice
Single session of LtAPD treatment applied to the CIN2 lesion under colposcopic guidance; outpatient, no anesthesia required.
Sham treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| LtAPD | Experimental | Treatment with low-thermal argon plasma devitalization Receives: Device: Treatment with low-thermal argon plasma devitalization |
| Sham | Sham comparator | Sham treatment Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 6 months
Secondary outcomes (4)
HPV remission rate
Percentage of patients with HPV remission, assessed by validated HPV testing and p16 immunohistochemistry
Measured: at 6 months
Cytological remission of CIN
Percentage of patients with cytological remission, assessed by Papanicolaou (PAP) smear according to the Bethesda classification system
Measured: 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)
Measured: 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
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start24 Sep 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia Grade 2 (CIN2)Studies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felix Neis, PD Dr., Principal investigator, University Hospital Tuebingen, Department of Women's Health, Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730645
- Sponsor's protocol ID
- MolGyn_BMBF_CINPLASTA
- Other IDs
- 01KG2503, DE-26-0000510067
- Acronym
- CINPLASTA
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07730645
- Acronym / sponsor ID
- CINPLASTA / MolGyn_BMBF_CINPLASTA
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LtAPD | Experimental | Device: Treatment with low-thermal argon plasma devitalizationTreatment with low-thermal argon plasma devitalization |
| Sham | Sham comparator | Device: Sham treatmentSham treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with low-thermal argon plasma devitalizationSingle session of LtAPD treatment applied to the CIN2 lesion under colposcopic guidance; outpatient, no anesthesia required. | Device | LtAPD |
| Sham treatmentSingle 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. | Device | Sham |
Primary outcome
Histopathological remission of CIN 2
Time frame: at 6 months
Percentage of patients with histopathologically confirmed remission of CIN 2 (absence of CIN 2 or higher grade lesion), assessed by cervical biopsy/histopathological evaluation
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Cervical Intraepithelial Neoplasia Grade 2 (CIN2)
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Enrolling by invitationObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Felix Neis, PD Dr. principal investigator
University Hospital Tuebingen, Department of Women's Health, Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with low-thermal argon plasma devitalization in people with Cervical Intraepithelial Neoplasia Grade 2 (CIN2) and Cervical Intraepithelial Neoplasia Grade 2, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Weiss, Prof. Dr. (+49 7071 29 82211, martin.weiss@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathological remission of CIN 2 (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.