ClinicalTrials.gg
RecruitingNCT07730645CINPLASTAUpdated Oct 1, 2026

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

An interventional study of Treatment with low-thermal argon plasma devitalization and Sham treatment in Cervical Intraepithelial Neoplasia Grade 2 (CIN2), Cervical Intraepithelial Neoplasia Grade 2 and CIN2, sponsored by University Hospital Tuebingen. Recruiting at 1 site in Germany. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 1, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 26 studies in Uterine Cervical Dysplasia with a site in Germany — 3 open to participants now, 3 under way, none of them phase 3. Uterine Cervical Dysplasia · Germany.

Planned enrollment
4th of 25
264 · median 201
Started
2026
the only one that year
No phase
17 of 26
3 open now
Registered
26th of 26
by date
Lead sponsor
3 of 26
University Hospital Tuebingen

Among the 26 studies in Uterine Cervical Dysplasia with a site in Germany, this one is the 4th largest by planned enrollment of the 25 interventional ones that give a count, is the only one that started in 2026, is one of 17 with no phase, and was the 26th registered.

Uterine Cervical Dysplasia

409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.

Browse Uterine Cervical Dysplasia studies →

Open to participants now

3 of the 26 studies in Uterine Cervical Dysplasia with a site in Germany are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 43 Uterine Cervical Dysplasia studies recruiting now, 19 (44%) set no upper age limit and 21 (49%) stop at 75 or younger; 3 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 40 Years · female · no healthy volunteers.

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02

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).

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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female sex
  • Age 18 - 40 years at the time of signing the
  • 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

Exclusion Criteria:

  • 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, condition or malignant tumor of any origin, as judged by the investigator
  • Participation in an interfering clinical study, as judged by the investigator
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
264 participants (estimated)

Study arms

  • Experimental
    LtAPD

    Treatment with low-thermal argon plasma devitalization

    Device: Treatment with low-thermal argon plasma devitalization

  • Sham comparator
    Sham

    Sham treatment

    Device: Sham treatment

Interventions

  • DeviceTreatment with low-thermal argon plasma devitalization

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

  • DeviceSham 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.

06

What researchers measure

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

    Time frame: at 6 months

Secondary outcomes

  1. HPV remission rate

    Percentage of patients with HPV remission, assessed by validated HPV testing and p16 immunohistochemistry

    Time frame: at 6 months

  2. Cytological remission of CIN

    Percentage of patients with cytological remission, assessed by Papanicolaou (PAP) smear according to the Bethesda classification system

    Time frame: at 6 months

  3. 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)

    Time frame: at baseline, intervention, 6 months

  4. 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

    Time frame: at 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — There is not a plan to make IPD available.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Mar 2029, 30 months after the start.

Of 78 non-industry interventional studies with no phase under Uterine Cervical Dysplasia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 30 months is above that.

Counting every sponsor, half of 82 studies reached it within 26 months; a quarter within 13 and three quarters within 54.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 1, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2026
First posted
Jul 28, 2026
StartActual
Sep 24, 2026was Aug 2026
Primary completionEst.
Mar 31, 2029
CompletionEst.
Sep 30, 2029
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 1, 2026
Sites
University Hospital Tuebingen, Department of Women's Health is now Recruiting
Oct 1, 2026
Start date
Aug 17, 2026→Sep 24, 2026 (actual)
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Not yet recruiting→Recruiting
    University Hospital Tuebingen, Department of Women's Health is now Recruiting
    Start date Aug 17, 2026→Sep 24, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07730645
Responsible party
Sponsor
First posted
Jul 28, 2026
Start date
Sep 24, 2026
Primary completion
Mar 31, 2029 (estimated)
Completion
Sep 30, 2029 (estimated)
Last update
Oct 1, 2026

Study contacts

Martin Weiss, Prof. Dr.
Contact
martin.weiss@med.uni-tuebingen.de
+49 7071 29 82211
Felix Neis, PD Dr.
principal investigator · University Hospital Tuebingen, Department of Women's Health, Tübingen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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